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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
167305–167328 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 11, 1980
COTTON UNDER CAST PADDING
K800195 · ITG
Winn Hirsch & Assoc.
Physical Medicine · 13d
Cleared Feb 11, 1980
UHR UNIVERSAL6HIP REPLACEMENT
K800207 · KWL
Osteonics Corp.
Orthopedic · 12d
Cleared Feb 08, 1980
DEXIDE DISPOSABLE PREP STICK W/IODOPHOR
K792270
Dexide, Inc.
General Hospital · 87d
Cleared Feb 07, 1980
ANESTHESIA & HOSPITAL SYRINGE HOLDER
K792520 · FMF
Medical Innovations Corp.
General Hospital · 63d
Cleared Feb 06, 1980
CONTINUOUS AMBULATORY DIALYSIS (CAPD)
K791512 · KDJ
Norton Performance Plastics Corp.
Gastroenterology & Urology · 201d
Cleared Feb 06, 1980
RECTAL LEAKAGE INHIBITOR
K792597 · KNT
Augustin Jones, M.D.
Gastroenterology & Urology · 51d
Cleared Feb 06, 1980
GAMBRO LUNDIA PLATE DIALYZER
K792611 · FJG
Gambro, Inc.
Gastroenterology & Urology · 50d
Cleared Feb 06, 1980
UNILAB CULTURING SET
K792648 · FRC
Sybron Corp.
General Hospital · 47d
Cleared Feb 06, 1980
CAPD TRANSFER SET JC9044
K792651 · KDJ
Travenol Laboratories, S.A.
Gastroenterology & Urology · 47d
Cleared Feb 06, 1980
ROYCO MODEL 951 CELL MIXER
K800104 · KSQ
Royco Instruments
Hematology · 21d
Cleared Feb 06, 1980
X-FLO
K800110 · HQE
Contemporary Surgical Systems, Inc.
Ophthalmic · 21d
Cleared Feb 06, 1980
EXTEMP/EXTEMP-V
K800153 · GAA
Pharma-Filter, Inc.
General & Plastic Surgery · 14d
Cleared Feb 06, 1980
TONGUE HOLDER/SALIVA EJECTOR
K800210 · DYN
Unitek Corp.
Dental · 5d
Cleared Feb 05, 1980
WRIGHT DOW CORNING SOFTGOODS W/DOW
K792269 · IPY
Dow Corning Wright
Physical Medicine · 88d
Cleared Feb 05, 1980
SHARPLAN 743, CO2 LASER SURGICAL SYSTEM
K792418 · GEX
Laser Industries , Ltd.
General & Plastic Surgery · 70d
Cleared Feb 05, 1980
PNEUPAC RESUSCITATOR INSTANT ACTION SET
K792451 · DRM
Pneupac , Ltd.
Cardiovascular · 64d
Cleared Feb 05, 1980
PNEUPAC RESUSCITATOR INSTANT ACTION SET
K792452 · DRM
Pneupac , Ltd.
Cardiovascular · 64d
Cleared Feb 05, 1980
PNEUPAC OXYGEN THERAPY UNIT
K792453 · BTL
Pneupac , Ltd.
Anesthesiology · 64d
Cleared Feb 05, 1980
PNEUPAC RESUSCITATOR INSTANT ACTION SET
K792454 · DRM
Pneupac , Ltd.
Cardiovascular · 64d
Cleared Feb 05, 1980
PNEUPAC VENTILATOR/RESUSCITATOR #2
K792455 · CBK
Pneupac , Ltd.
Anesthesiology · 64d
Cleared Feb 05, 1980
PNEUPAC VENTILATOR/RESUSCITATOR #3
K792456 · CBK
Pneupac , Ltd.
Anesthesiology · 64d
Cleared Feb 05, 1980
COMPRESSOR
K792457 · BTI
Pneupac , Ltd.
Anesthesiology · 64d
Cleared Feb 05, 1980
PNEUPAC TEST SET, PT.#500-A250
K792458 · DRM
Pneupac , Ltd.
Cardiovascular · 64d
Cleared Feb 05, 1980
PNEUPAC VENTILATOR/RESUSCITATOR
K792459 · CBK
Pneupac , Ltd.
Anesthesiology · 64d