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
70417–70440 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 15, 2003
SALINUM, ORCLAIR
K024148 · LFD
Sinclair Pharmaceuticals, Ltd.
Dental · 273d
Cleared Sep 15, 2003
3I DENTAL IMPLANTS
K030614 · DZE
Implant Innovations, Inc.
Dental · 201d
Cleared Sep 15, 2003
ACUMEN SURGICAL NAVIGATION SYSTEM
K031337 · HAW
Biomet, Inc.
Neurology · 140d
Cleared Sep 15, 2003
FLUORIDE VARNISH
K031932 · LBH
Dentsply Intl.
Dental · 84d
Cleared Sep 15, 2003
ASAP ARTHROSCOPE MODELS
K031972 · HRX
Asap Endoscopic Products GmbH
Orthopedic · 81d
Cleared Sep 15, 2003
INOVO, INC, ECONOMIZER CONSERVING REGULATOR
K031983 · NFB
Inovo, Inc.
Anesthesiology · 81d
Cleared Sep 15, 2003
RADIONICS NASHOLD BIOPSY NEEDLE - SINGLE USE
K032054 · HAW
Radionics, A Division of Tyco...
Neurology · 75d
Cleared Sep 15, 2003
KYPHX DIRECTIONAL INFLATABLE BONE TAMP, MODELS K16A AND K17A
K032212 · HRX
Kyphon, Inc.
Orthopedic · 56d
Cleared Sep 15, 2003
PRISMA M60/M100 SETS
K032431 · KDI
Gambro, Inc.
Gastroenterology & Urology · 40d
Cleared Sep 15, 2003
PASCO MIC AND MIC/ID PANELS, GEMIFLOXACIN (STREP)
K032518 · JWY
Bd Diagnostic Systems
Microbiology · 32d
Cleared Sep 15, 2003
NATURAL COMFORT BATTERY/ELECTRIC BREAST PUMP
K032566 · HGX
The First Years, Inc.
Obstetrics & Gynecology · 25d
Cleared Sep 12, 2003
HANDYDOP
K030466 · KNG
Elcat, GmbH
Radiology · 212d
Cleared Sep 12, 2003
AOSEPT CLEAR CARE CLEANING AND DISINFECTING SOLUTION
K030522 · LPN
Ciba Vision Corporation
Ophthalmic · 205d
Cleared Sep 12, 2003
THERMOSKIN CONDUCTIVE PADS
K030564 · GXY
United Pacific, Inc.
Neurology · 203d
Cleared Sep 12, 2003
MICROLIFE DIGITAL BASAL THERMOMETER, MODEL MT 1921
K030961 · LHD
Microlife Corp.
Obstetrics & Gynecology · 169d
Cleared Sep 12, 2003
S-MONOVETTE EDTA K2-GEL
K031359 · PJE
Sarstedt, Inc.
Chemistry · 135d
Cleared Sep 12, 2003
CD HORIZON SPINAL SYSTEM
K032033 · NKB
Medtronic Sofamor Danek
Orthopedic · 73d
Cleared Sep 12, 2003
SAFETY-MULTIFLY
K032150 · FPA
Sarstedt, Inc.
General Hospital · 60d
Cleared Sep 12, 2003
DURACON TOTAL KNEE SYSTEM
K032163 · MBH
Howmedica Osteonics Corp.
Orthopedic · 59d
Cleared Sep 12, 2003
QUANTUM WARP 10 LIGHT DELIVERY SYSTEM
K032229 · ILY
Quantum Devices, Inc.
Physical Medicine · 53d
Cleared Sep 12, 2003
INDUCTION AND SAMPLING MANIFOLD (OR STOPCOCK)
K032393 · FMG
Elcam Medical Acal
General Hospital · 39d
Cleared Sep 12, 2003
3.0T 8-CHANNEL CERVICAL-THORACIC-LUMBAR (CTL) ARRAY COIL
K032538 · MOS
Usa Instruments, Inc.
Radiology · 25d
Cleared Sep 12, 2003
POLESTAR N-20
K032541 · LNH
Odin Medical Technologies , Ltd.
Radiology · 25d
Cleared Sep 12, 2003
ACCU-CHEK ADVANTAGE SYSTEM
K032552 · NBW
Roche Diagnostics Corp.
Chemistry · 24d