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
82417–82440 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 11, 2000
OIS-2500 DIAGNOSTIC ULTRASOUND SYSTEM
K000415 · IYN
Optimal Imaging Systems, Inc.
Radiology · 63d
Cleared Apr 11, 2000
BODYGUARD
K000441 · FMI
Vital Signs, Inc.
General Hospital · 61d
Cleared Apr 11, 2000
FUTURE DIAGNOSTICS B.V. STAT-INTRAOPERATIVE INTACT PTH KIT
K000471 · CEW
Future Diagnostics B.V.
Chemistry · 57d
Cleared Apr 11, 2000
WALLACH QUANTUM 500 ELECTROSURGICAL GENERATOR
K000768 · EKZ
Wallach Surgical Devices, Inc.
Dental · 33d
Cleared Apr 11, 2000
SAMPLOK
K000777 · JKA
Itl Corporation Pty, Ltd.
Chemistry · 33d
Cleared Apr 11, 2000
HONIGUM
K000878 · ELW
Dmg USA, Inc.
Dental · 22d
Cleared Apr 11, 2000
POSSIS ANGIOJET RAPID THOMBECTOMY CATHETERS--F105 CATHETER MODEL 3030C, LF140...
K972610 · QEZ
Possis Medical, Inc.
Cardiovascular · 1002d
Cleared Apr 11, 2000
MALLORY/HEAD CALCAR REPLACEMENT WITH INTERLOCKING SLOTS BI-METRIC POROUS...
K990830 · LPH
Biomet, Inc.
Orthopedic · 396d
Cleared Apr 10, 2000
PRO.DUCT CATHETER, MODEL CTH03
K000135 · KNW
Pro. Duct Health, Inc.
Gastroenterology & Urology · 83d
Cleared Apr 10, 2000
PERRY-KOLBERG (PK) HA-COATED TITANIUM SLEEVE
K000151 · MQU
Integrated Orbital Implants, Inc.
Ophthalmic · 82d
Cleared Apr 10, 2000
E3 MICROPROB SERIES OF LASERS AND ACCESSORIES
K000192 · GEX
Martin Uram, MD
General & Plastic Surgery · 81d
Cleared Apr 10, 2000
DIGITAL INFLECTION RIGIDOMETER (DIR)
K000194 · LIL
Uroan Xxi Electromedicina
Gastroenterology & Urology · 80d
Cleared Apr 10, 2000
HEMISPHERE MODULAR CUP SYSTEM
K000321 · LPH
Ortho Development Corp.
Orthopedic · 68d
Cleared Apr 10, 2000
SYNCHRON SYSTEMS ALCOHOL REAGENT AND CALIBRATORS
K000410 · DMT
Beckman Coulter, Inc.
Toxicology · 62d
Cleared Apr 10, 2000
BETEL POWDER FREE LATEX EXAM GLOVES, CHLORINATED, WITH PROTEIN LABELING CLAIM...
K000652 · LYY
Betel Care Sdn. Bhd.
General Hospital · 42d
Cleared Apr 10, 2000
MODIFICATION TO MARSPO2, MODEL 2001
K000794 · DQA
Novametrix Medical Systems, Inc.
Anesthesiology · 28d
Cleared Apr 10, 2000
MODIFICATION TO JMS APHERESIS NEEDLE
K000843 · FIE
Jms Co., Ltd.
Gastroenterology & Urology · 26d
Cleared Apr 10, 2000
MODIFICATION TO JMS A.V. FISTULA NEEDLE SET
K000845 · FIE
Jms Co., Ltd.
Gastroenterology & Urology · 26d
Cleared Apr 10, 2000
VIRIDIA INFORMATION CENTER SOFTWARE FOR M3150A AND M3153A, VIRIDIA TELEMETRY...
K000854 · MHX
Agilent Technologies, Inc.
Cardiovascular · 25d
Cleared Apr 10, 2000
REDI-SCREEN
K000979 · LAF
Redwood Biotech, Inc.
Toxicology · 14d
Cleared Apr 10, 2000
MECA WRIST BLOOD PRESSURE METER, MODEL EW243 AND MODEL EW254
K991458 · DXN
Matsushita Electric Corp. of America
Cardiovascular · 350d
Cleared Apr 10, 2000
PURE WATER, INC.'S BICARB MIX, STORAGE AND DISTRIBUTION SYSTEM
K993272 · FIN
Pure Water, Inc.
Gastroenterology & Urology · 193d
Cleared Apr 10, 2000
TRANSLUMINAL BALLOON DILATATION CATHETER
K993305 · LIT
Boston Scientific Corp
Cardiovascular · 189d
Cleared Apr 10, 2000
STELA UT46 AND BT45/46 STRAIGHT TINED PACING LEADS, STELA UJ45 AND BJ44/45...
K993448 · DTB
Ela Medical, Inc.
Cardiovascular · 181d