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
80161–80184 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 13, 2001
MOJAVE CATARACT EXTRACTION SYSTEM
K003638 · HQC
Allergan, Inc.
Ophthalmic · 81d
Cleared Feb 13, 2001
SPECIALTY 55 & MULTIFOCAL (METHAFILCON A) SOFT (HYDROPHILIC CONTACT LENSES...
K003833 · LPL
Clearlab Pte , Ltd.
Ophthalmic · 64d
Cleared Feb 13, 2001
INFINION 1.5T MR IMAGING SYSTEM, MODEL MRI 100
K003853 · LNH
Philips Medical Systems (Cleveland),...
Radiology · 63d
Cleared Feb 13, 2001
FLOWRIDER FLOW DIRECTED MICRO CATHETER, MODEL 105-5065
K010004 · KRA
Micro Therapeutics, Inc.
Cardiovascular · 42d
Cleared Feb 13, 2001
ORBITER II CCI/SPECT ORBITER II CCI/SPECT
K010137 · KPS
Siemens Medical Solutions USA, Inc.
Radiology · 27d
Cleared Feb 13, 2001
BARD UTRAVERSE SMALL VESSEL PTA BALLOON DILATATION CATHETER
K010169 · DQY
C.R. Bard, Inc.
Cardiovascular · 26d
Cleared Feb 13, 2001
MODULITH LITHOTRIPSY, MODEL SLK FOR THE FRAGMENTATION OF URINARY AND UPPER...
K010340 · LNS
Karl Storz Lithotripsy-America, Inc.
Gastroenterology & Urology · 8d
Cleared Feb 12, 2001
LORENZ RESORBABLE DISTRACTOR SYSTEM
K002083 · JEY
Walter Lorenz Surgical, Inc.
Dental · 217d
Cleared Feb 12, 2001
INSTATRAK SYSTEM WITH FLUOROCAT, MODEL IT3500
K003510 · LLZ
Visualization Technology, Inc.
Radiology · 90d
Cleared Feb 12, 2001
ECHO VIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-2200
K003514 · IYN
Shimadzu Medical Systems
Radiology · 90d
Cleared Feb 12, 2001
ECHO VIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1200
K003515 · IYN
Shimadzu Medical Systems
Radiology · 90d
Cleared Feb 12, 2001
SPECIALTY 55 UV (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY...
K003526 · LPL
Specialty Ultravision, Inc.
Ophthalmic · 88d
Cleared Feb 12, 2001
SONOLITH PRAKTIS, ENDOUROLOGY TABLE PRAKTIS
K003529 · LNS
Edap Technomed, Inc.
Gastroenterology & Urology · 88d
Cleared Feb 12, 2001
SERENOCEM, MODEL BC 010
K003567 · NEA
Corinthian Medical , Ltd.
Ear, Nose, Throat · 84d
Cleared Feb 12, 2001
SERONO FOR USE WITH GONAL-F 1200IU MULTI-DOSE ONLY AT 600IU/ML SYRINGE
K003571 · FMF
Terumo Medical Corp.
General Hospital · 84d
Cleared Feb 12, 2001
AUTODELFIA NEONATAL IRT KIT, MODEL B005-112
K003668 · CGZ
Wallac OY
Chemistry · 76d
Cleared Feb 12, 2001
ASSERACHROM HPIA TEST KIT
K003767 · LCO
Diagnostica Stago, Inc.
Hematology · 68d
Cleared Feb 12, 2001
TOTAL BILIRUBIN
K003829 · CIG
Jas Diagnostics, Inc.
Chemistry · 63d
Cleared Feb 12, 2001
MODIFICATION TO AT HOME DRUG TEST, MODELS 9150, 9068, AND 9175
K003858 · MVO
Phamatech
Toxicology · 61d
Cleared Feb 12, 2001
VORTEX ACCESS SYSTEM
K010189 · LJT
Horizon Medical Products, Inc.
General Hospital · 21d
Cleared Feb 12, 2001
MXR-2000 MOBILE X-RAY UNIT
K010304 · IZL
Irom Imaging, Inc.
Radiology · 11d
Cleared Feb 09, 2001
3I CALCIUM SODIUM PHOSPHATE BONE CEMENT
K003493 · LYC
Biomet, Inc.
Dental · 88d
Cleared Feb 09, 2001
REMVIEW SLEEP RECORDER, MODEL 320
K003499 · LEL
Respironics, Inc.
Neurology · 88d
Cleared Feb 09, 2001
(DISPOSABLE) VAGINAL SPECULUM
K003540 · HIB
Feminica, Inc.
Obstetrics & Gynecology · 85d