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

Filters: Cleared only ×
174,955 results
92065–92088 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Sep 08, 1997
LOGIQ 1000 DIAGNOSTIC ULTRSOUND SYSTEM
K960527 · IYN
GE Medical Systems
Radiology · 580d
Cleared Sep 08, 1997
5 STAR MEDICAL ENDOSCOPE
K963354 · ODF
Five Star Medical, Inc.
Gastroenterology & Urology · 378d
Cleared Sep 08, 1997
AIRCAST VENA FLOW STERILE DISPOSABLE CUFFS
K964238 · JOW
Aircast, Inc.
Cardiovascular · 320d
Cleared Sep 08, 1997
BIOSURGICAL, CORP. MULTI CHAMBER SUCTION SYRINGE
K964597 · FMF
Biosurgical Corp.
General Hospital · 294d
Cleared Sep 08, 1997
CHASE THORACIC CATHETER
K971023 · DWF
Chase Medical, Inc.
Cardiovascular · 172d
Cleared Sep 08, 1997
DYE STOP AND SAVE - QUICKFILL
K971624 · FPA
Shepherd Laboratories, Inc.
General Hospital · 129d
Cleared Sep 08, 1997
STAPHYTECT PLUS/DRYSPOT STAPHYTECT PLUS
K972030 · JWX
Oxoid , Ltd.
Microbiology · 98d
Cleared Sep 08, 1997
DIGITIZER DIRECTOR (HSC025-01)
K972191 · LMD
Howtek, Inc.
Radiology · 90d
Cleared Sep 08, 1997
K 15 AUDIOMETER
K972221 · EWO
American Electromedics Corp.
Ear, Nose, Throat · 87d