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
74689–74712 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 20, 2002
LASER FIBER GF500
K021686 · GEX
W.O.M. World of Medicine AG
General & Plastic Surgery · 90d
Cleared Aug 20, 2002
20G SMA LASER FIBER, MODEL LF20
K021696 · GEX
Ophthalmed, LLC
General & Plastic Surgery · 90d
Cleared Aug 20, 2002
ENDOSCOPIC LIGHT SOURCE, MODEL XL300/L5
K021717 · GCT
World of Medicine Lemke GmbH
Gastroenterology & Urology · 89d
Cleared Aug 20, 2002
VASCLIP
K021745 · NJC
Vmbc, LLC
General & Plastic Surgery · 84d
Cleared Aug 20, 2002
FLASH-LITE LED DENTAL CURING LIGHT
K022184 · EBZ
Discus Dental, Inc.
Dental · 48d
Cleared Aug 20, 2002
SAPH-LOOP LIGATING LOOP
K022410 · GAT
Genzyme Biosurgery
General & Plastic Surgery · 27d
Cleared Aug 20, 2002
PHILIPS BABY THERMOMETER SET (SBC SC530)
K022542 · FLL
Philips Consumer Electronics
General Hospital · 19d
Cleared Aug 20, 2002
CAMINO INTRACRANIAL PRESSURE MONITORING CATHETER WITH LICOX IMC BOLT FITTING,...
K022553 · GWM
Integra Neurosciences
Neurology · 18d
Cleared Aug 19, 2002
INDUS TEXTILES TOWEL-STERILE AND NON-STERILE
K013958 · KKX
Indus Textiles, Inc.
General Hospital · 262d
Cleared Aug 19, 2002
DORNIER DIODE LASER FAMILY, INCLUDING MEDILAS D FIBERTOM, MEDILAS D SKINPULSE...
K021724 · GEX
Dornier Medtech America, Inc.
General & Plastic Surgery · 87d
Cleared Aug 19, 2002
FLAT PANEL DISPLAYS, ME SERIES & CCL SERIES
K021738 · LLZ
Totoku Electric Co., Ltd.
Radiology · 83d
Cleared Aug 19, 2002
SEAL & PROTECT PROTECTIVE SEALANT
K021805 · LBH
Dentsply Intl.
Dental · 77d
Cleared Aug 19, 2002
TOTAL KNEE FEMORAL COMPONENT
K022010 · JWH
Smith & Nephew, Inc.
Orthopedic · 61d
Cleared Aug 19, 2002
SMITH & NEPHEW IMAGE GUIDED SURGICAL SYSTEM FOR KNEE APPLICATIONS
K022460 · HAW
Smith & Nephew, Inc.
Neurology · 24d
Cleared Aug 16, 2002
MODULITH SLK LITHOTRIPTER
K011700 · LNS
Karl Storz Endoscopy
Gastroenterology & Urology · 441d
Cleared Aug 16, 2002
CLEARLIGHT PHOTOTHERAPHY SYSTEM, MODEL CL 420
K013623 · GEX
Curelight, Ltd.
General & Plastic Surgery · 284d
Cleared Aug 16, 2002
PALMO THERMOREGULATION INTERFACE ACCESSORY
K014210 · DWJ
Avacore Technologies, Inc.
Cardiovascular · 238d
Cleared Aug 16, 2002
ATHOSCAN FOR THE ATHOS LASER CONSTANS COOLING HAND PIECE FOR THE ATHOS LASER
K021650 · GEX
Quantel Medical
General & Plastic Surgery · 88d
Cleared Aug 16, 2002
CEMENT RESTRICTOR, SMALL AND LARGE
K021765 · JDK
Exactech, Inc.
Orthopedic · 79d
Cleared Aug 16, 2002
PRECISION POINT OF CARE BLOOD GLUCOSE TEST STRIP WITH TRUE MEASURE TECHNOLOGY
K021960 · LFR
Abbott Laboratories
Chemistry · 63d
Cleared Aug 16, 2002
MULTI FUCTIONAL REHABILITATION CHAIR
K022407 · INO
Raye'S, Inc.
Physical Medicine · 23d
Cleared Aug 16, 2002
HA MODULAR REACH PROXIMAL POROUS AND HA MODULAR REACH COLLARED PROXIMAL...
K022463 · LPH
Biomet Orthopedics, Inc.
Orthopedic · 21d
Cleared Aug 15, 2002
DB1 EMBRYO FREEZE
K011327 · MQG
Zander Medical Supplies, Inc.
Obstetrics & Gynecology · 471d
Cleared Aug 15, 2002
MININEPH HUMAN B2-MICROGLOBULIN KIT
K014270 · JZG
The Binding Site, Ltd.
Immunology · 231d