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
116449–116472 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 04, 1992
REFLAB SYSTEM PACK LIQUID FRUCTOSAMINE REAGENT
K920397 · LCP
Medical Analysis Systems, Inc.
Chemistry · 187d
Cleared Aug 04, 1992
FLEXIBLE CYSTOSCOPY INTRODUCING CATHETER
K921120 · FED
Cook Urological, Inc.
Gastroenterology & Urology · 148d
Cleared Aug 04, 1992
QUALTEX TUBE/CORD ORGANIZER
K921350 · KKX
Deroyal Industries, Inc.
General Hospital · 138d
Cleared Aug 04, 1992
CYNOSURE PHOTOGENICA P PIGMENTED LESION LASER
K921841 · GEX
Cynosure, Inc.
General & Plastic Surgery · 109d
Cleared Aug 04, 1992
FORCE GSU SYSTEM W/ LAPAROSCOPIC OPTION
K922090 · GEI
Valleylab, Inc.
General & Plastic Surgery · 91d
Cleared Aug 04, 1992
CALCIUM (AZ III) REAGENT
K922835 · CJY
King Diagnostics, Inc.
Chemistry · 53d
Cleared Aug 04, 1992
TURKEL PNEUMOTHORAX KIT
K923028 · GCB
Symbiosis Corp.
General & Plastic Surgery · 42d
Cleared Aug 04, 1992
ROCHE ABUSCREEN ONLINNE CALIBRATORS
K923340 · DKB
Roche Diagnostic Systems, Inc.
Toxicology · 40d
Cleared Aug 03, 1992
PETERS CARDIONYL(TM) SUTURE
K913102 · GAR
Promedica Products, Inc.
General & Plastic Surgery · 388d
Cleared Aug 03, 1992
FYMCO FLYER
K915416 · INI
Motion Dynamics
Physical Medicine · 245d
Cleared Aug 03, 1992
TIMOX OXYGEN TIMER
K920360 · BXP
Medical Fittings, Inc.
Anesthesiology · 189d
Cleared Aug 03, 1992
PSK FEMORAL AND TIBIAL INSERT COMPONENT
K920426 · JWH
Orthomet, Inc.
Orthopedic · 182d
Cleared Aug 03, 1992
FEMORAL AND ALL POLY TIBIAL TRAY COMPONENTS
K920698 · JWH
Orthomet, Inc.
Orthopedic · 182d
Cleared Aug 03, 1992
AIR STAR
K920954 · BTI
Infrasonics Corp.
Anesthesiology · 159d
Cleared Aug 03, 1992
DIASTAT ANTI-CARDIOLIPIN KIT
K921265 · MID
Shield Diagnostics, Ltd.
Immunology · 140d
Cleared Aug 03, 1992
ADAPTING SLEEVE KIT MODEL 4023
K921318 · DTD
Siemens-Pacesetter, Inc.
Cardiovascular · 137d
Cleared Aug 03, 1992
WHITE ASH - FRAXINUS AMERICANA (T15) ALLERGEN DISC
K921574 · DHB
Hycor Biomedical, Inc.
Immunology · 123d
Cleared Aug 03, 1992
STAODYN TUWAVE
K921668 · IPF
Staodyne, Inc.
Physical Medicine · 117d
Cleared Aug 03, 1992
BIOTROL BICARBONATE STANDARDS
K921855 · JIS
Biotrol, USA, Inc.
Chemistry · 108d
Cleared Aug 03, 1992
TILTING MAG
K921896 · IZH
Continental X-Ray Corp.
Radiology · 103d
Cleared Aug 03, 1992
BARD PCA II PUMP WITH PROGRAM CARTRIDGES
K921994 · MEA
C.R. Bard, Inc.
General Hospital · 97d
Cleared Aug 03, 1992
LAPAROSCOPIC INTRODUCER
K922082 · GCJ
Endomedix
General & Plastic Surgery · 91d
Cleared Aug 03, 1992
ENDOSCOPIC RETRIEVAL BASKET
K922114 · FFL
Intramed Laboratories, Inc.
Gastroenterology & Urology · 90d
Cleared Aug 03, 1992
COLTENE A.R.T. BOND
K922615 · KLE
Coltene/Whaledent, Inc.
Dental · 62d