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
124729–124752 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 17, 1990
PERCOR STAT-DL 8.5 FR INTRA-AORTIC BALLOON
K896497 · DSP
Datascope Corp.
Cardiovascular · 276d
Cleared Aug 17, 1990
ANESTHESIA BREATHING CIRCUITS
K900428 · CAI
Med-Tek Corp.
Anesthesiology · 199d
Cleared Aug 17, 1990
PERNECZKY ANEURYSM CLIP
K901312 · HCH
Von Zeppelin GmbH
Neurology · 150d
Cleared Aug 17, 1990
RTS TECHNOLOGY IRIDIUM 192 SOURCES
K901589 · JAQ
Rts Technology, Inc.
Radiology · 143d
Cleared Aug 17, 1990
PRIME CARE NEONATAL/PEDIATRIC TRACHEOSTOMY TUBE
K901920 · BTO
Primecare, Inc.
Anesthesiology · 109d
Cleared Aug 17, 1990
MAG RESON DIAG DEV ACCESS SPEC PURP REC ONLY COIL
K901952 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 108d
Cleared Aug 17, 1990
WINGED INFUSION SET
K902166 · FPA
Therex Corp.
General Hospital · 94d
Cleared Aug 17, 1990
RESPIRONICS BIPAP PRESSURE ALARM (BIPAP P.A.)
K902276 · CAP
Respironics, Inc.
Anesthesiology · 88d
Cleared Aug 17, 1990
BUSSE BAC/SHIELD
K902297 · BSY
Busse Hospital Disposables, Inc.
Anesthesiology · 86d
Cleared Aug 17, 1990
SHAW II HEMOSTATIC SURGERY SYSTEM
K902307 · GEI
Hemostatic Surgery Corp.
General & Plastic Surgery · 87d
Cleared Aug 17, 1990
PARKER MICROPUMP MODEL 2100
K902309 · FRN
Chathamborough Research Group, Inc.
General Hospital · 86d
Cleared Aug 17, 1990
MODIFIED PROSTATIC URETHROPLASTY BALLOON CATHETER
K902370 · FAH
Boston Scientific Corp
Gastroenterology & Urology · 80d
Cleared Aug 17, 1990
PENLON BREATHING SYSTEM PRESSURE MONITOR
K902381 · CAP
Penlon, Inc.
Toxicology · 79d
Cleared Aug 17, 1990
PHILIPS INTEGRIS C2000 SYSTEM
K902542 · IZI
Philips Medical Systems North...
Radiology · 72d
Cleared Aug 17, 1990
XPEED COMPUTED TOMOGRAPHY X-RAY SYSTEM
K902557 · JAK
Toshiba America Medical Systems, In.C
Radiology · 67d
Cleared Aug 17, 1990
COLLAGEN SHIELD FOR ACUTE CARE
K902558 · MOE
Vitaphore Corp.
Ophthalmic · 67d
Cleared Aug 17, 1990
I.C. MEDICAL SMOKE EVACUATOR ACTIVATOR
K902611 · FYD
I.C Medical, Inc.
General Hospital · 65d
Cleared Aug 17, 1990
PINNACLE IMAGE PROCESSING SYSTEM
K902648 · LLZ
Medasys, Inc.
Radiology · 63d
Cleared Aug 17, 1990
STERI-SHIELD
K902677 · FXY
Biomedical Devices, Inc.
General Hospital · 60d
Cleared Aug 17, 1990
KODAK X-OMAT 460 RA PROCESSOR
K902732 · IXW
Eastman Kodak Company
Radiology · 57d
Cleared Aug 17, 1990
SUCTION CATHETER, STERILE
K902814 · BSY
Orion Life Systems, Inc.
Anesthesiology · 50d
Cleared Aug 17, 1990
MILENIA(TM) PCP
K902960 · LCM
Diagnostic Products Corp.
Toxicology · 43d
Cleared Aug 17, 1990
EMIT ETHYL ALCOHOL CALIBRATORS AND CONTROLS
K903152 · DKB
Syva Co.
Toxicology · 30d
Cleared Aug 17, 1990
MONI-TROL XL AND L UNASSAYED LIQUID CHEMISTRY
K903190 · JJY
Medical Analysis Systems, Inc.
Chemistry · 29d