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
167713–167736 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 20, 1979
POLAROID LAND CAMERA FOR ENDOSCOPY
K792512 · FEM
Polaroid Corp.
Gastroenterology & Urology · 15d
Cleared Dec 20, 1979
IMPLANTABLE PROGRAMMABLE UNIPOLAR
K792519 · DXY
Telectronics, Inc.
Cardiovascular · 14d
Cleared Dec 20, 1979
CONTINU-FLO ADMIN. SET CODE 2C/200
K792538 · FPA
Travenol Laboratories, S.A.
General Hospital · 10d
Cleared Dec 20, 1979
MASTER I.V. DIAL LOCK
K792560 · FPA
The Master Medical Corp.
General Hospital · 9d
Cleared Dec 20, 1979
THE ARALUEN CARRIER
K792566 · FPP
Araluen, Inc.
General Hospital · 7d
Cleared Dec 19, 1979
PONCY PAK
K791843 · KGO
Poncy, Inc.
General Hospital · 91d
Cleared Dec 19, 1979
WHITE SEALING CAP
K791915 · DQO
Quinton, Inc.
Cardiovascular · 85d
Cleared Dec 19, 1979
CARDIVAN BLOOD PRESSURE MONITOR
K792226 · DRT
Paramed Technology, Inc.
Cardiovascular · 44d
Cleared Dec 19, 1979
AMS YEAST BIOCHEMICAL CARD
K792231 · JXB
Vitek Systems, Inc.
Microbiology · 44d
Cleared Dec 19, 1979
PENTEX BRONCHOFIBERSCOPE MODEL FB-17A
K792267 · EOQ
Pentax Precision Instrument Corp.
Ear, Nose, Throat · 44d
Cleared Dec 19, 1979
BRAIN HEART INFUSION W/PABA, O.1%,
K792276 · JSG
Bd Becton Dickinson Vacutainer...
Microbiology · 36d
Cleared Dec 19, 1979
CULTURIA EMB/COLUMBIA CNA W/5% SHEEP
K792284 · JXA
Clinical Convenience Products, Inc.
Microbiology · 36d
Cleared Dec 19, 1979
MR-VP MEDIUM
K792286 · JSH
Isle Media and Sterile Products, Inc.
Microbiology · 36d
Cleared Dec 19, 1979
KF STREPTOCOCCUS AGAR
K792287 · JSJ
Isle Media and Sterile Products, Inc.
Microbiology · 36d
Cleared Dec 19, 1979
TRYPTONE BROTH (TRYPTOPHANE BROTH)
K792288 · JSH
Isle Media and Sterile Products, Inc.
Microbiology · 36d
Cleared Dec 19, 1979
IPOS BREAST PROSTHESIS
K792372 · GBI
Ipos KG
General & Plastic Surgery · 23d
Cleared Dec 19, 1979
ARTERIAL BLOOD FILTER, MODEL AF-10
K792450 · DTM
Bentley Laboratories, Inc.
Cardiovascular · 16d
Cleared Dec 19, 1979
CENTRIX MKIV ENDODONTIC DELIVERY
K792461 · EIC
Centrix, Inc.
Dental · 16d
Cleared Dec 19, 1979
AMBU PAEDI ANAESTHESIA SYSTEM
K792499 · CAI
Narco Air-Shields
Anesthesiology · 15d
Cleared Dec 19, 1979
MINI-H-FIXATION
K792561 · JEC
Geny Medical, Inc.
Orthopedic · 7d
Cleared Dec 19, 1979
MA-1 VENTILATOR & TIMETER AIRCOMPRESSOR
K792564 · CBK
Eastern Anesthesia, Inc.
Anesthesiology · 7d
Cleared Dec 19, 1979
COUNTER UNIT
K792571 · BWF
Empire Plastics Manufacturer
Anesthesiology · 6d
Cleared Dec 19, 1979
EMPIRE SPIROMETER
K792572 · BZK
Empire Plastics Manufacturer
Anesthesiology · 6d
Cleared Dec 19, 1979
CASTROVIEJO VASCULAR SCISSORS
K792576 · DWS
Edward Weck, Inc.
Cardiovascular · 6d