FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
91825–91848 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 13, 1997
FLUID MANAGEMENT SYSTEM
K972284 · FRN
Belmont Instrument Corp.
General Hospital · 147d
Cleared Nov 13, 1997
PEDO CUSH PEDO CUDDLE
K972446 · FMQ
Cavity Free Kids, Inc.
General Hospital · 136d
Cleared Nov 13, 1997
PIVOTAL SCISSOR
K972510 · GEI
Urohealth Systems, Inc.
General & Plastic Surgery · 133d
Cleared Nov 13, 1997
LANG DENTAL RESIN A97 FIBRED PINK
K972553 · EBI
Lang Dental Mfg. Co., Inc.
Dental · 128d
Cleared Nov 13, 1997
OPTI-MAX ANGLED CROWN POST FOR EXTERNALLY-HEXED IMPLANTS, IN 15 DEGREE AND 25...
K972769 · DZE
Opti-Max
Dental · 112d
Cleared Nov 13, 1997
PLUS EPF ACETABULAR CUP
K972931 · LWJ
Hhl Consulting
Orthopedic · 97d
Cleared Nov 13, 1997
IMCOR EXTERNALLY HEXED, SELF-TAPPING SCREW IMPLANT SURGICAL DRILLING SYSTEM
K973049 · DZE
Imcor
Dental · 90d
Cleared Nov 13, 1997
REALVIEW TELEMEDICINE SYSTEM
K973065 · LLZ
Vcom Systems, Inc.
Radiology · 87d
Cleared Nov 13, 1997
PLUS-FIT ACETABULAR CUP
K973077 · LWJ
Plus Orthopedics
Orthopedic · 87d
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