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
106945–106968 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 15, 1994
454A ELECTROSURGICAL ANALYZER
K942627 · GEI
Hogan & Hartson
General & Plastic Surgery · 74d
Cleared Aug 15, 1994
BIG BEN
K942650 · DXN
Rud Riester GmbH & CO KG
Cardiovascular · 76d
Cleared Aug 15, 1994
MODEL M1310A, SERIES 50T FETAL TELEMETRY SYSTEM
K942887 · HGM
Hewlett-Packard Co.
Obstetrics & Gynecology · 56d
Cleared Aug 15, 1994
NIL
K943263 · HQY
Sing Wah International Enterprises ,...
Ophthalmic · 39d
Cleared Aug 15, 1994
ALPHA SOLAR SYSTEM TANNING BED
K943656 · LEJ
Heartland Tan Systems
General & Plastic Surgery · 18d
Cleared Aug 12, 1994
XANCHOR SUTURE ATTACHMENT DEVICE
K932041 · JDR
Orthopaedic Biosystems
Orthopedic · 472d
Cleared Aug 12, 1994
SLICES
K941812 · LNH
Microsignal Corp.
Radiology · 122d
Cleared Aug 12, 1994
ALGIDENCO AND ALGIPRINT IMPRESSION MATERIALS
K942219 · ELW
Robert W. Bauer & Assoc., Inc.
Dental · 98d
Cleared Aug 12, 1994
MISTASSIST
K942789 · LRD
The Merlin Corp.
Ear, Nose, Throat · 59d
Cleared Aug 12, 1994
ULTRA HYDROPHILIC ALGINAE
K943475 · ELW
Essential Dental Systems, Inc.
Dental · 24d
Cleared Aug 11, 1994
CARDIOPULMONARY METABOLIC MEASUEMENT CART
K921565 · BZL
Quiton Instrument Co.
Anesthesiology · 862d
Cleared Aug 11, 1994
MINIPACK 911-STC
K925701 · CCK
Pace Tech, Inc.
Anesthesiology · 637d
Cleared Aug 11, 1994
NK PRESSURE-SPECIFIED SENSORY DEVICE, MODEL PSSD-001
K934368 · LLN
Nk Biotechnical Engineering Co.
Neurology · 338d
Cleared Aug 11, 1994
CARPAL TUNNEL SYSTEM
K940234 · HRX
Richard Wolf Medical Instruments Corp.
Orthopedic · 205d
Cleared Aug 11, 1994
FLOW DIRECT THERMODILUT BALLOON CATH HEPARIN COATED
K940547 · DYG
J-Lloyd Medical, Inc.
Cardiovascular · 185d
Cleared Aug 11, 1994
MEDFLATOR II(TM) DISPOSABLE INFLATION DEVICE
K940896 · MAV
Medex, Inc.
Cardiovascular · 168d
Cleared Aug 11, 1994
SILK*SKIN SCAR TREATMENT
K941197 · MDA
Puritas Health Care, Inc.
General & Plastic Surgery · 150d
Cleared Aug 11, 1994
SPINAL ANESTHESIA TRAY
K941343 · CAZ
Spinal Specialties, Inc.
Anesthesiology · 143d
Cleared Aug 11, 1994
OPSIS THORACOSCOPY VIDEO SYSTEM THORACICCAM AND THORACICCAM 360
K941950 · GCJ
Baxter Healthcare Corp
General & Plastic Surgery · 112d
Cleared Aug 11, 1994
CONTINENTAL 45 (HEFILCON A) SPHERICAL & ASPHERIC CONTACT LENSES
K943490 · LPL
Continental Soft Lens, Inc.
Ophthalmic · 23d
Cleared Aug 11, 1994
FACONNABLE EYEWEAR (SUNGLASSES)
K943568 · HQY
Blink Designs, Inc.
Ophthalmic · 20d
Cleared Aug 11, 1994
SUNGLASSES
K943609 · HQY
Konwan Optical Xiamen Co., Ltd.
Ophthalmic · 17d
Cleared Aug 11, 1994
DISPOSABLE MANUAL RESUSCITATOR
K943617 · BTM
Puritan-Bennett
Anesthesiology · 15d
Cleared Aug 10, 1994
IVAC VENTED SYRINGE ADAPTER ADMINISTRATION SETS
K934095 · FPA
Y
General Hospital · 352d