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
78937–78960 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 20, 2001
PTW DOSIMETRY DIODE, T60008
K010916 · IYE
Ptw-New York Corp.
Radiology · 85d
Cleared Jun 20, 2001
SEALAPEX 4
K010940 · KIF
Sybron Dental Specialties, Inc.
Dental · 83d
Cleared Jun 20, 2001
DRIDAU OPIATE ASSAY
K011150 · DJG
Microgenics Corp.
Toxicology · 65d
Cleared Jun 20, 2001
THIN FILM DRESSING FOR ULTRASOUND EXAM
K011284 · ITX
Martin E. Wendelken
General & Plastic Surgery · 54d
Cleared Jun 20, 2001
ZIEHM VISION
K011292 · OWB
Ziehm International, Inc.
Radiology · 51d
Cleared Jun 20, 2001
NIPRO SAFETOUCH SCALP VEIN AND BLOOD COLLECTION SET
K011297 · FOZ
Nipro Medical Corp.
General Hospital · 51d
Cleared Jun 20, 2001
Q-RAD RADIOGRAPHIC SYSTEM
K011486 · KPR
Quantum Medical Imaging, LLC
Radiology · 36d
Cleared Jun 20, 2001
HYPERFORM OCCLUSION BALLOON SYSTEM, MODEL 104-4470, 104-4471, 104-4770, 104-4771
K011656 · MJN
Micro Therapeutics, Inc.
Cardiovascular · 22d
Cleared Jun 20, 2001
ACCU-CHEK ACTIVE SYSTEM
K011738 · NBW
Roche Diagnostics Corp.
Chemistry · 15d
Cleared Jun 19, 2001
PFC SIGMA LUGGED TIBIAL TRAY
K003026 · JWH
DePuy Orthopaedics, Inc.
Orthopedic · 264d
Cleared Jun 19, 2001
K'FIX
K010847 · NDL
Avanta Orthopaedics, Inc.
Orthopedic · 90d
Cleared Jun 19, 2001
MERIDIAN-PORTABLE
K010897 · GZO
Meridian Co., Ltd.
Neurology · 85d
Cleared Jun 19, 2001
FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IMN) MODEL B
K010901 · HSB
Disc-O-Tech Medical Technologies, Ltd.
Orthopedic · 85d
Cleared Jun 19, 2001
MEDPOR QUAD MOTILITY IMPLANT
K010902 · HPZ
Porex Surgical, Inc.
Ophthalmic · 85d
Cleared Jun 19, 2001
MODIFICATION TO PROLITE PULSED LIGHT SYSTEM
K010927 · GEX
Medical Bio Care Sweden AB
General & Plastic Surgery · 83d
Cleared Jun 19, 2001
PROLITE VL PULSED LIGHT SYSTEM
K010928 · GEX
Medical Bio Care Sweden AB
General & Plastic Surgery · 83d
Cleared Jun 19, 2001
KSEA MINIATURE TELESCOPE AND ACCESSORIES
K010987 · HRX
KARL STORZ Endoscopy-America, Inc.
Orthopedic · 78d
Cleared Jun 19, 2001
FIXION INTERLOCKING PROXIMAL FEMORAL NAILING SYSTEM
K010988 · HSB
Disc-O-Tech Medical Technologies, Ltd.
Orthopedic · 78d
Cleared Jun 19, 2001
RESORBABLE HAMMERTOE PIN
K011137 · JDW
Biomet, Inc.
Orthopedic · 67d
Cleared Jun 19, 2001
ARTHREX BIO-TRANSFIX
K011172 · MNU
Arthrex, Inc.
Orthopedic · 63d
Cleared Jun 19, 2001
SIMPLICITY SOFT YP INFUSION SET FOR USE WITH THE MINIMED PARAGIGM INFUSION PUMPS
K011187 · FPA
Sterling Medivations, Inc.
General Hospital · 62d
Cleared Jun 19, 2001
TORNIER TOTAL ELBOW PROSTHESIS
K011567 · JDB
Tornier
Orthopedic · 29d
Cleared Jun 19, 2001
OCU-FLEX 55 SPHERICAL, TORIC,THIN ZONE TORIC,ASPHERICAL,TORIC ASPHERICAL AND...
K011577 · LPL
Ocu-Ease Optical Products, Inc.
Ophthalmic · 28d
Cleared Jun 19, 2001
ARTHROCARE CONTROLLER, MODEL H2000
K011634 · GEI
Arthrocare Corp.
General & Plastic Surgery · 21d