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
74185–74208 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Aug 15, 2002
TL10 TENSYMETER BLOOD PRESSURE MONITORING SYSTEM
K020537 · DXN
Tensys Medical, Inc.
Cardiovascular · 177d
Cleared Aug 15, 2002
INTRAORAL IMAGING SYSTEM, MODEL SUNI-RAY
K021718 · MUH
Suni Imaging Microsystems, Inc.
Radiology · 84d
Cleared Aug 15, 2002
FORTITUDE CEMENT RESTRICTOR
K021719 · JDK
Spinal Concepts, Inc.
Orthopedic · 84d
Cleared Aug 15, 2002
DEGALL LAPAROSCOPIC GALLBLADDER EXTRACTOR
K021747 · GCI
Surgicon, Inc.
General & Plastic Surgery · 79d
Cleared Aug 15, 2002
ALTAIRE MAGNETIC RESONANCE IMAGING SYSTEM
K021751 · MOS
Hitachi Medical Systems America, Inc.
Radiology · 79d
Cleared Aug 15, 2002
KSEA QUADRO SWITCH
K021776 · OCX
Karl Storz Endoscopy
Gastroenterology & Urology · 78d
Cleared Aug 15, 2002
CANNABINOID ENZYME IMMUNOASSAY, CATALOG 0070, 0071
K021887 · LDJ
Lin-Zhi International, Inc.
Toxicology · 69d
Cleared Aug 15, 2002
MODIFICATION TO POTASSIUM NITRATE-POLYCARBOXYLATE DENTAL CEMENT
K022025 · EJK
Milton Hodosh, M.D.
Dental · 56d
Cleared Aug 15, 2002
VITEK GRAM POSITIVE SUSCEPTIBILITY (GPS) CARD FOR LINEZOLID
K022045 · LON
bioMerieux, Inc.
Microbiology · 52d