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
73129–73152 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 02, 2002
MOTEX LATEX EXAMINATION GLOVES, POWDER-FREE
K020837 · LYY
Shanghai Motex Healthcare Co., Ltd.
General Hospital · 263d
Cleared Dec 02, 2002
SANIDAD TENS-DUO MODE GP8016N
K021430 · GZJ
Rolor Electronics Corp.
Neurology · 213d
Cleared Dec 02, 2002
V.A.C. INSTILLAMAT (VACUUM ASSISTED CLOSURE INSTILLAMAT
K021501 · OMP
Kinetic Concepts, Inc.
General & Plastic Surgery · 207d
Cleared Dec 02, 2002
WRIST IMPLANT
K021859 · JWJ
Avanta Orthopaedics, Inc.
Orthopedic · 179d
Cleared Dec 02, 2002
HOME CARE JELLY
K022494 · GYB
Roc Chinese-European Industrial...
Neurology · 126d
Cleared Dec 02, 2002
J.P. 3-WHEELED SCOOTER, ES-350 CITYBUG II/ RABBIT
K022518 · INI
Roc Chinese-European Industrial...
Physical Medicine · 125d
Cleared Dec 02, 2002
SOLERA MAGNUM THROMBECTOMY CATHETER, 55 CM, MODEL BAC SMG 007 055 & SOLERA...
K022640 · MCW
Bacchus Vascular, Inc.
Cardiovascular · 116d
Cleared Dec 02, 2002
SCOOTER MARS SERIES, MODEL TL-588
K022698 · INI
Teh Lin Prosthetic & Orthopaedic, Inc.
Physical Medicine · 111d
Cleared Dec 02, 2002
MODEL AMI1200 C-ARM
K022911 · JAA
Integrity Practice Management, Inc.
Radiology · 90d
Cleared Dec 02, 2002
EVENFLO COMFORT SELECT AUTO-CYCLE BREAST PUMP KIT
K022933 · HGX
Evenflo Company, Inc.
Obstetrics & Gynecology · 89d
Cleared Dec 02, 2002
MODULAR HEAD BONE SCREW
K022952 · HWC
Biomet, Inc.
Orthopedic · 88d
Cleared Dec 02, 2002
HOVEROUND REHAB SEATING SYSTEM FOR POWER WHEELCHAIRS
K022993 · ITI
Hoveround Corp.
Physical Medicine · 84d
Cleared Dec 02, 2002
COLLATEK HYDROGEL
K022995 · MGQ
Biocore Medical Technologies, Inc.
General & Plastic Surgery · 84d
Cleared Dec 02, 2002
SR VIVOTAC/SR ORTHOTAC, MODIFIER MONOMER & POLYMER
K023035 · ELM
Ivoclar Vivadent, Inc.
Dental · 81d
Cleared Dec 02, 2002
SST SALIVA SUPPORTING TABLETS
K023046 · LED
Sinclair Pharmaceuticals, Ltd.
Pathology · 81d
Cleared Dec 02, 2002
KSEA SPINOSCOPE
K023187 · HRX
Karl Storz Endoscopy
Orthopedic · 69d
Cleared Dec 02, 2002
CYNOVAD ZIRKON
K023327 · EIH
Cynovad
Dental · 59d
Cleared Dec 02, 2002
EXPLORER POWERED WHEELCHAIR
K023485 · ITI
Evermed Corp.
Physical Medicine · 46d
Cleared Dec 02, 2002
TRELLIS-6 PERIPHERAL INFUSION SYSTEM (140CM CATHETER LENGTH 10CM INFUSION...
K023514 · QEY
Bacchus Vascular, Inc.
Cardiovascular · 42d
Cleared Dec 02, 2002
DERMAGRIP-P POWDER FREE PINK NITRILE EXAMINATION GLOVES, NON-STERILE
K023517 · LZA
Wrp Asia Pacific Sdn. Bhd.
General Hospital · 45d
Cleared Dec 02, 2002
EVLT KIT AND D15PLUS AND D30PLUS DIODE
K023543 · GEX
Diomed, Inc.
General & Plastic Surgery · 41d
Cleared Dec 02, 2002
COMFORT AGILE SCOOTER, LY-EW303
K023581 · INI
Comfort Orthopedic Co., Ltd.
Physical Medicine · 39d
Cleared Nov 29, 2002
ELECSYS PROBNP CALCHECK
K020883 · JJX
Roche Diagnostics Corp.
Chemistry · 256d
Cleared Nov 29, 2002
INSTANT-VIEW PROPOXYPHENE (PPX) URINE TEST
K022915 · JXN
Alfa Scientific Designs, Inc.
Chemistry · 87d