FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
88537–88560 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 30, 1998
HEMOCHRON JR. MIOCROCOAGULATION CITRATED PT
K972866 · GJS
International Technidyne Corp.
Hematology · 422d
Cleared Sep 30, 1998
THYMOSTAT ELISA FOR THE DETECTION OF HUMAN IGG,M AND A ANTI-RABBIT IGG...
K973203 · DAK
Sangstat Medical Corp.
Immunology · 400d
Cleared Sep 30, 1998
OMNIFLATOR 6630(6-630-00)
K973447 · HIF
Northgate Technologies, Inc.
Obstetrics & Gynecology · 384d
Cleared Sep 30, 1998
DUOSTAR
K974170 · GEI
Mti Corp./ Electrostar S.A.-Haiti
General & Plastic Surgery · 329d
Cleared Sep 30, 1998
AVOCET PT
K980839 · JPA
Avocet Medical, Inc.
Hematology · 210d
Cleared Sep 30, 1998
DIGITAL CLINICAL THERMOMETER, MODELS ST-833A & ST-834A
K981337 · FLL
Mesure Technology
General Hospital · 170d
Cleared Sep 30, 1998
SYSMEX AUTOMATED COAGULATION ANALYZER CA-500
K981711 · JPA
Dade Behring, Inc.
Hematology · 156d
Cleared Sep 30, 1998
SYNTHETIC EXAMINATION GLOVE, POWDERED
K981876 · LYZ
Hsing YI Plastics Processing Co, Ltd.
General Hospital · 125d
Cleared Sep 30, 1998
METRON QA-IDS I.V. PUMP TESTER
K982020 · FRN
Metron U.S., Inc.
General Hospital · 113d
Cleared Sep 30, 1998
UMECO OPTIMA 694 RUBY LASER SYSTEM
K982113 · GEX
Umeco, Inc.
General & Plastic Surgery · 106d
Cleared Sep 30, 1998
OUTBOUND DISPOSABLE SYRINGE INFUSER OUTBOUND 2 DISPOSABLE PUMP
K982256 · MEB
Mckinley, Inc.
General Hospital · 96d
Cleared Sep 30, 1998
SOMATOM PLUS 4WITH VOLUME ZOOM CT SCANNERS
K982349 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 86d
Cleared Sep 30, 1998
EAGLESOFT CHAIRSIDE
K982422 · LLZ
Eaglesoft, A Patterson Co.
Radiology · 79d
Cleared Sep 30, 1998
NITRILE PATIENT EXAMINATION GLOVE
K982440 · LZA
Perusahaan Getah Asas Sdn. Bhd.
General Hospital · 78d
Cleared Sep 30, 1998
TEMPFIL F - 2
K982459 · EBG
Sybron Dental Specialties, Inc.
Dental · 77d
Cleared Sep 30, 1998
EXTRACRANIAL RADIOTHERAPY SYSTEM
K982463 · IYE
Howmedica, Inc.
Radiology · 77d
Cleared Sep 30, 1998
HANDMASTER NMS1
K982482 · IPF
N.E.S.S. Nuromuscular Electrical...
Physical Medicine · 76d
Cleared Sep 30, 1998
ORTHO IMPLANT AND ACCESSORIES
K982509 · OAT
Straumann USA
Dental · 72d
Cleared Sep 30, 1998
MEDIVISION CYSTOSCOPE
K982620 · FAJ
Medivision Scope Service Center, Inc.
Gastroenterology & Urology · 65d
Cleared Sep 30, 1998
AESCULAP NEEDLESCOPIC INSTRUMENT SYSTEM
K982623 · GCJ
Aesculap, Inc.
General & Plastic Surgery · 64d
Cleared Sep 30, 1998
JOAN II
K982648 · EFQ
Celanese Acetate Co.
General & Plastic Surgery · 63d
Cleared Sep 30, 1998
DISPOSABLE VINYL SYNTHETIC EXAM GLOVES, POWDER FREE
K982704 · LYZ
Shanghai Antares Industries, Inc.
General Hospital · 58d
Cleared Sep 30, 1998
SEARE BIOMEDICAL CHIN IMPLANTS
K982752 · FWP
Seare Biomedical Corp.
General & Plastic Surgery · 55d
Cleared Sep 30, 1998
SEARE BIOMEDICAL NASAL IMPLANTS
K982753 · FZE
Seare Biomedical Corp.
General & Plastic Surgery · 55d