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
80089–80112 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Feb 20, 2001
MICROSPEED EC MOTORSYSTEM GD650/GD653
K003612 · HBC
Aesculap, Inc.
Neurology · 90d
Cleared Feb 20, 2001
PLGA PIN, MODEL...
K003659 · HTY
Bionx Implants, Inc.
Orthopedic · 84d
Cleared Feb 20, 2001
SYNTHES HAMSTRING LOOP
K003700 · HWC
Synthes (Usa)
Orthopedic · 81d
Cleared Feb 20, 2001
THROMBOREL S
K003870 · GJS
Dade Behring, Inc.
Hematology · 67d
Cleared Feb 20, 2001
TOTAL BILIRUBIN REAGENT
K003892 · CIG
Intersect Systems, Inc.
Chemistry · 64d
Cleared Feb 20, 2001
DIMENSION ENZYMATIC CARBONATE (ECO2) CALIBRATOR, CATALOG DC137
K010208 · JIT
Dade Behring, Inc.
Chemistry · 28d
Cleared Feb 16, 2001
COMPAT REPLACEMENT GASTROSTOMY TUBE KIT, MODEL 0974XX
K001916 · KNT
Novartis Nutrition Corp.
Gastroenterology & Urology · 238d
Cleared Feb 16, 2001
WATER PURIFICATION SYSTEM FOR HEMODIALYSIS
K002045 · FIP
Total Water Treatment Systems, Inc.
Gastroenterology & Urology · 226d
Cleared Feb 16, 2001
X-SEPT TRANSSEPTAL SHEATH AND TRANSITION CATHETER, MODEL MV-03-09-90,...
K002054 · DYB
Appriva Medical, Inc.
Cardiovascular · 225d
Cleared Feb 16, 2001
ACTICOAT COMPOSITE DRESSING
K002466 · FRO
Westaim Biomedical, Inc.
General & Plastic Surgery · 189d
Cleared Feb 16, 2001
VAN ANDLE DILATION, EMERALD GUIDEWIRE, MODEL VAD6, 502-726
K002650 · FGE
Bentec Medical, Inc.
Gastroenterology & Urology · 175d
Cleared Feb 16, 2001
REGUTHERM 952 THERMOGRAPHIC SYSTEM
K003130 · LHQ
Sie-Med, Inc.
Radiology · 133d
Cleared Feb 16, 2001
MEDLINE BLOCKADE OR RESISTAT SURGICAL GOWNS AND SURGGICAL DRAPES
K003755 · FYA
Medline Industries, Inc.
General Hospital · 73d
Cleared Feb 16, 2001
BOSTON EO (ENFLUFOCON B) CONTACT LENS FOR ORTHOKERATOLGY
K003932 · HQD
Polymer Technology
Ophthalmic · 58d
Cleared Feb 16, 2001
BOSTON EQUALENS II (OPRIFOCON A) CONTACT LENS FOR ORTHOKERATOLGY
K003933 · MUW
Polymer Technology
Ophthalmic · 58d