FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

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174,955 results
91321–91344 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 13, 1997
ENDOPATH ULTRA-RETRACTOR/ ENDOPATH VESSEL DISSECTOR
K973139 · GCJ
Ethicon Endo-Surgery, Inc.
General & Plastic Surgery · 84d
Cleared Nov 13, 1997
HOOK ELECTRODE, NEEDLE ELECTRODE, COAGULATION BUTTON ELECTRODE
K973341 · GEI
Richard Wolf Medical Instruments Corp.
General & Plastic Surgery · 69d
Cleared Nov 13, 1997
CYNOSURE PHOTOGENICA ER LASER
K973498 · GEX
Cynosure, Inc.
General & Plastic Surgery · 59d
Cleared Nov 13, 1997
DURALASTIC ANATOMICAL NASAL IMPLANTS
K973573 · FZE
Hanson Medical, Inc.
General & Plastic Surgery · 55d
Cleared Nov 13, 1997
ELECSYS VITAMIN B12 ASSAY
K973702 · CDD
Boehringer Mannheim Corp.
Chemistry · 48d
Cleared Nov 13, 1997
SILICONE CARVING BLOCK
K973728 · MIB
Hanson Medical, Inc.
General & Plastic Surgery · 44d
Cleared Nov 13, 1997
EYE SYS VISTA
K973756 · HLQ
Eyesys Technologies, Inc.
Ophthalmic · 42d
Cleared Nov 13, 1997
ALLEGIANCE KWIK HEAT WARM PERINEAL PACK
K973770 · IMD
Allegiance Healthcare Corp.
Physical Medicine · 42d
Cleared Nov 13, 1997
VIRGO ANCA SCREEN KIT
K973822 · MOB
Hemagen Diagnostics, Inc.
Immunology · 37d
Cleared Nov 13, 1997
PR 3 ANTIBODY KIT
K973823 · MOB
Hemagen Diagnostics, Inc.
Immunology · 37d
Cleared Nov 13, 1997
VIRGO PANCO KIT
K973824 · MOB
Hemagen Diagnostics, Inc.
Immunology · 37d
Cleared Nov 13, 1997
DHEA-S
K973897 · JKC
Kmi Diagnostics, Inc.
Chemistry · 30d
Cleared Nov 13, 1997
PROGESTERONE ELISA
K973898 · JLS
Kmi Diagnostics, Inc.
Chemistry · 30d
Cleared Nov 13, 1997
ASPARTATE AMINOTRANSFERASE-SL ASSAY, CATALOGUE NUMBER 319-10, 319-30
K974001 · CIT
Diagnostic Chemicals , Ltd.
Chemistry · 23d
Cleared Nov 12, 1997
TUTTNAUER PREVACUUM TABLE AUTOCLAVE
K962282 · FLE
Tuttnauer U.S.A Co, Ltd.
General Hospital · 518d
Cleared Nov 12, 1997
CAHP HIGH PERFORMANCE CELLULOSE DIACETATE (CAPILLARY, HOLLOW FIBER)
K970654 · MSE
Baxter Healthcare Corp
Gastroenterology & Urology · 264d
Cleared Nov 12, 1997
CA CELLULOSE ACETATE HOLLOW FIBER DIALYZER (CA-90)
K970661 · MSE
Baxter Healthcare Corp
Gastroenterology & Urology · 264d
Cleared Nov 12, 1997
BCI MODEL 6004 NIBP MONITOR (6004)
K970801 · DXN
Bci Intl., Inc.
Cardiovascular · 253d
Cleared Nov 12, 1997
CASTLE SERIES 100 STEAM STERILIZERS (STRAIGHTLINE)
K970907 · FLE
Getinge/Castle, Inc.
General Hospital · 246d
Cleared Nov 12, 1997
MIE FALCON, DATEX ENGSTROM FLEXIMA II
K971030 · BSZ
Medical and Industrial Equipment
Anesthesiology · 237d
Cleared Nov 12, 1997
NEUROTRONICS POLYSOMNOGRAPHY SYSTEM 101
K971803 · MNR
Neurotronics, Inc.
Anesthesiology · 184d
Cleared Nov 12, 1997
ODI COMPRESSION HIP SCREW SYSTEM
K971993 · KTT
Orthopaedic Designs, Inc.
Orthopedic · 167d
Cleared Nov 12, 1997
DEPUY DURALOC ACETABULAR CUP SYSTEM
K972596 · LPH
Depuy, Inc.
Orthopedic · 124d
Cleared Nov 12, 1997
3M TEGADERM TRANSPARENT DRESSING, 3M TEGADERM TRANSPARENT DRESSING (FIRST AID...
K973036 · MGP
3M Healthcare
General & Plastic Surgery · 90d