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
82921–82944 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 12, 2000
REGENT SKINDENDE EXAM GLOVE, REGENT BIOGEL D, REGENTBIOGEL DIAGNOSTIC...
K991677 · LYY
London International Group, Inc.
General Hospital · 331d
Cleared Apr 12, 2000
IQ CHAMBERS
K992553 · KXF
Dormer Laboratories, Inc.
General Hospital · 257d
Cleared Apr 12, 2000
A&D MEDICAL UT-101 LIFESOURCE DIGITAL EAR THEROMETER
K993116 · FLL
A&D Engineering, Inc.
General Hospital · 205d
Cleared Apr 12, 2000
VINYL PATIENT EXAMINATION GLOVES-PRE-POWDERED
K994099 · LYZ
Evergreen Medical Produts (Jingxing)...
General Hospital · 131d
Cleared Apr 11, 2000
RGP MULTI-PURPOSE SOLUTION ID 100136
K000148 · MRC
Alcon Laboratories
Ophthalmic · 84d
Cleared Apr 11, 2000
CORTEK ARTHROSCOPE
K000198 · HRX
Cortek Endoscopy, Inc.
Orthopedic · 81d
Cleared Apr 11, 2000
SERIES 7700 MOBILE C-ARM, COMPACT 7700 MOBILE C-ARM, COMPACT 7700 PLUS MOBILE...
K000221 · OWB
Ge Dec Medical Systems
Radiology · 78d
Cleared Apr 11, 2000
MULTI PURPOSE FLEX ARRAY COIL : MODEL 235 SERIES
K000345 · MOS
Medical Advances, Inc.
Radiology · 68d
Cleared Apr 11, 2000
SCREENERS COCAINE TEST
K000350 · DIO
Drug Detection Devices, Ltd.
Toxicology · 68d
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