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
80065–80088 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 22, 2001
MINIENDO III
K003640 · ELB
Sybron Dental Specialties, Inc.
Dental · 87d
Cleared Feb 22, 2001
SUTUREGROOVE WEIGHT SIZING SET
K003646 · MML
Iop, Inc.
Ophthalmic · 87d
Cleared Feb 22, 2001
MEDGE PLATFORMS SONOCUBIC 3D ULTRASOUND SOFTWARE
K003672 · IYO
Medge Platforms, Inc.
Radiology · 86d
Cleared Feb 22, 2001
TAUT-INSUFFLATION NEEDLE
K003703 · HIF
Taut, Inc.
Obstetrics & Gynecology · 83d
Cleared Feb 22, 2001
URETEROSCOPES
K003806 · FGB
Global Endoscopy, Inc.
Gastroenterology & Urology · 76d
Cleared Feb 22, 2001
CYSTOSCOPES
K003807 · FAJ
Global Endoscopy, Inc.
Gastroenterology & Urology · 76d
Cleared Feb 22, 2001
VISULAS YAG II
K003885 · GEX
Carl Zeiss, Inc.
General & Plastic Surgery · 69d
Cleared Feb 22, 2001
MEDTRONIC PS MEDICAL NEUROPEN ENDOSCOPE AND OPTICAL ACCESSORIES
K003914 · GWG
Medtronic PS Medical
Neurology · 65d
Cleared Feb 22, 2001
ADAPT LAPAROSCOPIC PORT & ADAPT REDUCER CAP
K010007 · GCJ
Taut, Inc.
General & Plastic Surgery · 51d
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