Alert Text Revised Attachment Revised Title/Description
- 89-01 03/19/1997 10/26/2006
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ELECTRICAL MUSCLE STIMULATORS AND IONTOPHORESIS DEVICES
- 89-04 08/02/2001 11/12/2008
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DWPE OF DEVICES FROM FIRMS THAT HAVE NOT MET DEVICE GMP'S (REV)
- 89-06 01/26/1988
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AUTOMATIC DETENTION OF 'SUPER PULSE' ELECTRONIC DEVICES
- 89-07 08/08/2001
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DWPE OF GYNECOLOGICAL DEVICES MANUFACTURED BY LEIBAN INTERNATIONAL
- 89-08 08/13/2001 12/17/2008
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DWPE OF CLASS III DEVICES W/O APPROVED PMA'S OR IDE'S AND OTHER DEVICES NOT EQUIVALENT OR NO 510K
- 89-09 08/13/2001 04/05/2006
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DWPE OF LIQUID INJECTABLE SILICON (LIS) LABELED MEDICAL GRADE OR INTENDED FOR MEDICAL USE
- 89-10 05/29/1992
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AUTOMATIC DETENTION OF IMPLANTABLE DEVICES MADE FROM PROPLAST
- 89-11 11/03/1999 11/03/1999
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DET W/O PHY EXAM OF CLASS III DEVICES W/O PMA'S OR PDP'S
- 89-12 08/30/2001 01/12/2007
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DWPE OF HEARING AID DEVICES LABELED AS PERSONAL LISTENING AMPLIFICATION PRODUCTS
- 89-13 07/29/1998 10/07/2002
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DET. W/O PHYS. EXAM OF ELECTRODE LEAD WIRES AND PATIENT CABLES THAT DO NOT COMPLY WITH APPLICABLE PERFORMANCE STANDARD
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