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
79561–79584 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 22, 2001
ELECTRICATOR MODEL 26000
K010025 · GEI
Dermatologic Lab & Supply, Inc.
General & Plastic Surgery · 50d
Cleared Feb 22, 2001
HRH-127 HEAD ARRAY COIL
K010140 · MOS
Mri Devices Corp.
Radiology · 36d
Cleared Feb 22, 2001
FIRSTSAVE BIPHASIC MODEL #9200 AND 9210
K010214 · MKJ
Survivalink Corp.
Cardiovascular · 30d
Cleared Feb 21, 2001
PERIPHERAL ARTERIAL TONOMETER-PAT 1000RD DEVICE
K001852 · DQK
Itamar Medical (C.M.) 1997 , Ltd.
Cardiovascular · 247d
Cleared Feb 21, 2001
ACTICOAT FOAM DRESSING, ALGISITE M CALCIUM ALGINATE DRESSING
K002896 · FRO
The Westaim Corp.
General & Plastic Surgery · 156d
Cleared Feb 21, 2001
VAGINAL PORT, NON-STERILE / 600065, VAGINAL PORT, STERILE / 600073
K002912 · HIB
Sterinc
Obstetrics & Gynecology · 156d
Cleared Feb 21, 2001
COMPLETE BRAND MULTI-PURPOSE SOLUTION
K003252 · LPN
Allergan, Inc.
Ophthalmic · 127d
Cleared Feb 21, 2001
MEDITHERM MED2000
K003332 · LHQ
Meditherm, Inc.
Radiology · 120d
Cleared Feb 21, 2001
MEDRELIEF
K003507 · GZJ
Healthonics, Inc.
Neurology · 100d
Cleared Feb 21, 2001
AURORA
K003651 · LNH
Aurora Imaging Technology, Inc.
Radiology · 86d
Cleared Feb 21, 2001
SPECIALITY 56 UV (HEFILCON C) SOFT (HYDROPHILLIC) CONTACT LENS FOR DAILY WEAR
K003789 · LPL
Specialty Ultravision, Inc.
Ophthalmic · 75d
Cleared Feb 21, 2001
STRYKER HEATED INSUFFLATOR TUBE SET
K003792 · HIF
Stryker Corp.
Obstetrics & Gynecology · 75d
Cleared Feb 21, 2001
EZ-HCG URINE(PREGNANCY TEST)
K003856 · JHI
Biomerica, Inc.
Chemistry · 70d
Cleared Feb 21, 2001
NUCAMMA BI90
K003882 · KPS
Is2 Research, Inc.
Radiology · 68d
Cleared Feb 21, 2001
PHOSPHORUS REAGENT
K003912 · CEO
Jas Diagnostics, Inc.
Chemistry · 64d
Cleared Feb 21, 2001
OCU-FLEX-53 THIN ZONE TORIC AND THIN ZONE TORIC ASPHERICAL (OCUFILCON) SOFT...
K003996 · LPL
Ocu-Ease Optical Products, Inc.
Ophthalmic · 57d
Cleared Feb 21, 2001
OCU-FLEX-49 THIN ZONE TORIC AND THIN Z0NE TORIC ASPHERICAL (HIOXIFILCON B)...
K004000 · LPL
Ocu-Ease Optical Products, Inc.
Ophthalmic · 57d
Cleared Feb 21, 2001
CONTROL MODULE ALGORITHM ENHANCEMENT FOR THE MODEL S500-ST AND MODEL S400
K010210 · GEI
Curon Medical, Inc.
General & Plastic Surgery · 29d
Cleared Feb 21, 2001
CHALLENGER DIRECT COMPOSITE
K010219 · EBF
International Dental Research
Dental · 28d
Cleared Feb 21, 2001
GORE-TEX DUALMESH PLUS BIOMATERIAL WITH HOLES
K010228 · FTL
W.L. Gore & Associates, Inc.
General & Plastic Surgery · 28d
Cleared Feb 21, 2001
SONOSITE HAND-CARRIED ULTRASOUND SYSTEM
K010374 · IYN
Sonosite,Inc.
Radiology · 14d
Cleared Feb 21, 2001
TE ME NA EPIDURAL CATHETER
K991259 · BSO
Te ME NA S.A.R.L.
Anesthesiology · 680d
Cleared Feb 20, 2001
EHS SERIES TABLE TOP AUTOCLAVE, MODELS 2540 AND 3870
K003470 · FLE
Tuttnauer Co. , Ltd.
General Hospital · 104d
Cleared Feb 20, 2001
SOVEREIGN BIPOLAR INSTRUMENTS FOR GYNECOLOGY
K003608 · HGI
Aesculap, Inc.
Obstetrics & Gynecology · 90d