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
92569–92592 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 10, 1997
2D VOG - VIDEO-OCULOGRAPHY
K972243 · GWN
Sensomotoric Instruments, GmbH
Neurology · 86d
Cleared Sep 10, 1997
OSTEO BOS SYSTEM
K972323 · HRS
Osteonics Corp.
Orthopedic · 82d
Cleared Sep 10, 1997
IMPACT AIR 45 HANDPIECE FOR ENDODONTIC USE
K972375 · EFB
Glenwood, LLC
Dental · 77d
Cleared Sep 10, 1997
IMPACT AIR 45 HANDPIECE FOR PERIODONTAL USE
K972376 · EFB
Glenwood, LLC
Dental · 77d
Cleared Sep 10, 1997
PROLENE POLYPROPYLENE MESH HERNIA DEVICE NONABSORBABLE SYNTHETIC SURGICAL MESH
K972412 · FTL
Ethicon, Inc.
General & Plastic Surgery · 76d
Cleared Sep 10, 1997
INNERWEAR, GENTLEMEN'S CHOICE W/NONOXYNOL-9
K972429 · LTZ
Custom Services Intl., Inc.
Obstetrics & Gynecology · 75d
Cleared Sep 10, 1997
EXTRAWEAR, GENTLEMEN'S CHOICE W/NONOXYNOL-9
K972430 · LTZ
Custom Services Intl., Inc.
Obstetrics & Gynecology · 75d
Cleared Sep 10, 1997
AMSINO SUCTION CATHETER
K973199 · BSY
Amsino Intl., Inc.
Anesthesiology · 15d
Cleared Sep 10, 1997
K&W 2-PIECE TAKE-APART INSTRUMENTS(VARIOUS)
K973259 · OCZ
Medical Creative Technologies, Inc.
Gastroenterology & Urology · 12d
Cleared Sep 09, 1997
QUICK COUPLING DEVICE FOR DENTAL PROSTHESES
K950260 · DZE
Dr. Joseph E. Grasso, D.D.S.
Dental · 960d
Cleared Sep 09, 1997
DEVICE FOR PROVIDING QUICK COUPLING FOR DENTAL PROSTHESES
K950261 · DZE
Dr. Joseph E. Grasso, D.D.S.
Dental · 960d
Cleared Sep 09, 1997
KIS-III NON-SUBMERGED IMPLANT, SCREWS AND CYLINDERS
K961381 · DZE
The Emerging Technologies Group
Dental · 539d
Cleared Sep 09, 1997
VYGON UMBILICAL CATHETHER INSERTION TRAY
K963196 · FOZ
Vygon Corp.
General Hospital · 390d
Cleared Sep 09, 1997
FUKUDA DENSHI DYNASCOPE MODEL DS-5800 CENTRAL STATION MONITOR
K970585 · DSI
Fukuda Denshi USA, Inc.
Cardiovascular · 207d
Cleared Sep 09, 1997
BLOOD MONITOR PUMP
K970591 · KDI
Baxter Healthcare Corp
Gastroenterology & Urology · 203d
Cleared Sep 09, 1997
LEADCARE BLOOD LEAD TESTING SYSTEM
K971640 · DOF
Esa, Inc.
Toxicology · 130d
Cleared Sep 09, 1997
BOUFFANT CAP
K972187 · KKX
American Seal Co.
General Hospital · 91d
Cleared Sep 09, 1997
RHEUMATOID FACTOR LATEX-ENHANCED IMMUNOTURBIDIMETRIC TEST KIT
K972220 · DHR
Randox Laboratories, Ltd.
Immunology · 89d
Cleared Sep 09, 1997
SHOE COVER
K972227 · FYF
American Seal Co.
General & Plastic Surgery · 88d
Cleared Sep 09, 1997
OPUS D-DIMER
K972316 · GHH
Behring Diagnostics, Inc.
Hematology · 81d
Cleared Sep 09, 1997
JIMMY JOHN III RECTAL NOZZEL, MODEL CIT
K972455 · KPL
Colon Therapeutics
Gastroenterology & Urology · 70d
Cleared Sep 09, 1997
PUNCTUAL OCCLUDER
K972523 · LZU
Odyssey Medical, Inc.
Ophthalmic · 64d
Cleared Sep 09, 1997
CLINITEK MICROALBUMIN REAGENT STRIPS
K972706 · CJG
Bayer Corp.
Chemistry · 50d
Cleared Sep 09, 1997
AVL OMNI ANALYZER
K972733 · CGA
Avl Scientific Corp.
Chemistry · 50d