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
94753–94776 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 03, 1997
MULTITAK SS SUTURE SYSTEM
K964532 · MBI
Bonutti Research
Orthopedic · 83d
Cleared Feb 03, 1997
FAVC: FEMORAL ARTERY VASCULAR CLAMP - MODEL NUMBER RMDS 1000-15, RMDS...
K964662 · DXC
Rmds, Inc.
Cardiovascular · 74d
Cleared Feb 03, 1997
STORZ E8010 ERGOTEC/PREMIERE ADAPTOR
K964743 · HQE
Storz Instrument Co.
Ophthalmic · 69d
Cleared Feb 03, 1997
ENTRACARE THERMOMTER MODEL 1000
K964851 · FLL
Entracare Corp.
General Hospital · 62d
Cleared Feb 03, 1997
MEKANIKA'S SPINAL STIFFNESS GAUGE (SSG)
K964933 · LBB
Mekanika, Inc.
Neurology · 55d
Cleared Jan 31, 1997
CONCEPTUS FALLOPIAN TUBE CATHETEIZATION WITH MICROENDOSCOPY SYSTEM
K962587 · MKO
Conceptus, Inc.
Obstetrics & Gynecology · 214d
Cleared Jan 31, 1997
IMAGYN FALLOPOSCOPY SYSTEM
K963580 · MKO
Imagyn Medical, Inc.
Obstetrics & Gynecology · 147d
Cleared Jan 31, 1997
STRYKER STRYKEFLOW ELECTROCAUTERY PROBES
K963765 · GEI
Stryker Endoscopy
General & Plastic Surgery · 134d
Cleared Jan 31, 1997
SHUNT TAP WITH ICP MONITORING ACCESS PORT
K964371 · JXG
Integra Neurocare, LLC
Neurology · 91d
Cleared Jan 31, 1997
RADIONICS CONTOUR FLEX PLUS VALVE
K964386 · JXG
Radionics, Inc.
Neurology · 88d
Cleared Jan 31, 1997
CHASE VESSEL OCCLUDER
K964390 · MJN
Chase Medical, Inc.
Cardiovascular · 88d
Cleared Jan 31, 1997
ULTRA-ETCH STAT
K965060 · EBF
Ultradent Products, Inc.
Dental · 44d
Cleared Jan 30, 1997
STERILEMAX
K953938 · FLE
Barnstead/Thermolyne Corp.
General Hospital · 528d
Cleared Jan 30, 1997
P1OP2B OR P1O92T
K954674 · FYA
Kay Borch A/S
General Hospital · 478d
Cleared Jan 30, 1997
PATIENT EXAMINATION GLOVE
K961521 · LYZ
Shanghai PT Plastics Enterprise...
General Hospital · 283d
Cleared Jan 30, 1997
DISETRONIC D-MODEM
K961975 · FRN
Disetronic Medical Systems
General Hospital · 255d
Cleared Jan 30, 1997
COVER-ALL, DRAPE-IT-ALL, CHAIR SLEVE, X-RAY SLEEVE, HEADREST COVER
K962288 · MMP
Pinnacle Products, Inc.
General Hospital · 230d
Cleared Jan 30, 1997
DEXTREN CLEAR POWDER-FREE HYPOALLERGENIC SURGICAL GLOVES
K962813 · KGO
Maxxim Medical
General Hospital · 195d
Cleared Jan 30, 1997
SPECIALTY T TORIC (OCUFILCON A) CONTACT LENS FOR DAILY WEAR
K963764 · LPL
Specialty Ultravision, Inc.
Ophthalmic · 133d
Cleared Jan 30, 1997
CUTANEOUS COMPRESSION DEVICE FOR USE IN HEMODIALYSIS
K964041 · KOC
Robert R. Stevens
Gastroenterology & Urology · 114d
Cleared Jan 30, 1997
GE STERILE DISPOSABLE EQUIPMENT COIL COVER
K964141 · MOS
Contour Fabricators, Inc.
Radiology · 107d
Cleared Jan 30, 1997
BIPAP DUET SYSTEM
K964363 · BZD
Respironics, Inc.
Anesthesiology · 90d
Cleared Jan 30, 1997
CES VASCULAR OCCLUSION SYSTEM
K964367 · HCG
Cordis Neurovascular, Inc.
Neurology · 90d
Cleared Jan 30, 1997
WESTERN SURGICAL REUSABLE LAPAROSCOPIC TROCAR SYSTEM
K964436 · HET
Western Surgical Instrument Co.
Obstetrics & Gynecology · 86d