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
71929–71952 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 04, 2003
NITRILE EXAMINATION GLOVES, POWDER FREE, POLYMER COATED, PURPLE COLOR
K030245 · LZA
Arista Latindo Industrial Ltd. P.T
General Hospital · 70d
Cleared Apr 04, 2003
MEDLEY SYSTEM WITH MEDICATION MANAGEMENT SYSTEM (MMS)
K030459 · FRN
Alaris Medical Systems, Inc.
General Hospital · 52d
Cleared Apr 04, 2003
SAVIEW 55 MULTIFOCAL (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR...
K030548 · LPL
St. shine Optical Co., Ltd.
Ophthalmic · 43d
Cleared Apr 04, 2003
FLEXIBLE TIP THERMOMETER, MODEL 011206
K030673 · FLL
Global Treasure Industries , Ltd.
General Hospital · 31d
Cleared Apr 04, 2003
RADIONICS SINGLE USE GROUND PAD (DGP-HP)
K030697 · GEI
Radionics, Inc.
General & Plastic Surgery · 29d
Cleared Apr 04, 2003
WU'S POWERED WHEELCHAIR, MAMBO 3
K030707 · ITI
Wu'S Tech Co., Ltd.
Physical Medicine · 29d
Cleared Apr 04, 2003
WU'S POWERED WHEELCHAIR, MAMBO 5
K030709 · ITI
Wu'S Tech Co., Ltd.
Physical Medicine · 29d
Cleared Apr 04, 2003
FRONTIER MODEL X5
K030783 · ITI
Vestil Manufacturing Corp.
Physical Medicine · 23d
Cleared Apr 04, 2003
SYNTHES (USA) LCP PROXIMAL FEMUR PLATE AND SCREWS
K030858 · HRS
Synthes (Usa)
Orthopedic · 17d
Cleared Apr 04, 2003
RABBIT MOBILE STANDING FRAME
K030882 · IPL
R82 A/S
Physical Medicine · 15d
Cleared Apr 04, 2003
SWITCHBLADE
K030890 · GEI
Snowden Pencer, Inc.
General & Plastic Surgery · 14d
Cleared Apr 03, 2003
FORTUNE ALL SILICONE STOMACH (GASTRIC) TUBES, MODEL 2020
K022112 · KNT
Fortune Medical Instrument Corp.
Gastroenterology & Urology · 279d
Cleared Apr 03, 2003
GALEMED PEAK FLOW METER, MODELS 3751/3752
K022124 · BZH
Galemed Corp.
Anesthesiology · 276d
Cleared Apr 03, 2003
STERRAD 50 & STERRAD 100S STERILIZERS
K023290 · FLF
Advanced Sterilization Products
General Hospital · 183d
Cleared Apr 03, 2003
FIBERFILL AGP
K023818 · KIF
Pentron Clinical Technologies
Dental · 139d
Cleared Apr 03, 2003
MICROCAP PLUS/NPB-75
K024300 · DQA
Oridion Medical 1987 , Ltd.
Anesthesiology · 100d
Cleared Apr 03, 2003
ADMIRAL .035 DILATATION CATHETER, MODELS ADL0720-80,ADL0720-135,ADL0820-80,...
K030062 · LIT
Avantec Vascular Corp.
Cardiovascular · 86d
Cleared Apr 03, 2003
CT HDR TANDEM/RING APPLICATOR WITH RECTAL RETRACTOR
K030110 · JAQ
Mick Radio-Nuclear Instruments, Inc.
Radiology · 80d
Cleared Apr 03, 2003
SMALL HIGH SPEED MOTOR DRILL SYSTEM
K030172 · HBE
Brasseler USA I, L.P.
Neurology · 76d
Cleared Apr 03, 2003
P2 POLYETHER
K030318 · ELW
Heraeus Kulzer, Inc.
Dental · 63d
Cleared Apr 03, 2003
TUOHY EPIDURAL NEEDLE
K030562 · BSP
Epimed International, Inc.
Anesthesiology · 41d
Cleared Apr 03, 2003
IVS INTRODUCER SET, MODEL 1003
K030723 · DYB
Integrated Vascular Systems, Inc.
Cardiovascular · 27d
Cleared Apr 03, 2003
PRECISET DAT AMPHETAMINE
K030826 · DIJ
Quantimetrix Corp.
Toxicology · 20d
Cleared Apr 02, 2003
COBRA BIPOLAR CLAMP, MODEL 15902
K023288 · GEI
Boston Scientific EP Technologies
General & Plastic Surgery · 182d