FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
124657–124680 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 09, 1990
ITE HEARING AID, SOUND MED RUBY MODEL
K903862 · ESD
Improved Hearing Service, Inc.
Ear, Nose, Throat · 71d
Cleared Oct 09, 1990
ITE HEARING AID, SOUND MED OPAL MODEL
K903863 · ESD
Improved Hearing Service, Inc.
Ear, Nose, Throat · 71d
Cleared Oct 09, 1990
ITE HEARING AID, PEARL MODEL
K903864 · ESD
Improved Hearing Service, Inc.
Ear, Nose, Throat · 71d
Cleared Oct 09, 1990
ITE HEARING AID, SOUND MED AMETHYST MODEL
K903865 · ESD
Improved Hearing Service, Inc.
Ear, Nose, Throat · 71d
Cleared Oct 09, 1990
MODEL 9444 TELETRACE II ECG MONITORING SYSTEM
K903960 · DXH
Medtronic Vascular
Cardiovascular · 42d
Cleared Oct 09, 1990
PNEUMOTHORAX KIT, MODIFICATION
K904021 · JDC
Arrow Intl., Inc.
Orthopedic · 41d
Cleared Oct 09, 1990
ACCU-FLO* UNITIZED SHUNT
K904120 · JXG
Codman & Shurtleff, Inc.
Neurology · 33d
Cleared Oct 09, 1990
BIOLINK AUDIOMETER SOFTWARE ACCESSORY
K904270 · EWO
Micro Audiometrics Corp.
Ear, Nose, Throat · 21d
Cleared Oct 05, 1990
HIGH FUSING WHITE CERAMIC SOLDER
K895058 · EJT
Leach and Dillon Co., Inc.
Dental · 423d
Cleared Oct 05, 1990
HIGH FUSING YELLOW CERAMIC SOLDER
K895059 · EJT
Leach and Dillon Co., Inc.
Dental · 423d
Cleared Oct 05, 1990
INTERSPEC 2 MHZ, TRANSCRANIAL PULSED WAVE DOPPLER
K900155 · ITX
Interspec, Inc.
Radiology · 266d
Cleared Oct 05, 1990
VITACHROM-L DENTAL PORCELAIN KIT
K901982 · EIH
Vident
Dental · 156d
Cleared Oct 05, 1990
VITADUR-N DENTAL PORCELAIN KIT
K902105 · EIH
Vident
Dental · 150d
Cleared Oct 05, 1990
MINISPACE(TM) IUI CATHETER
K902171 · HDR
Pharmacia, Inc.
Obstetrics & Gynecology · 144d
Cleared Oct 05, 1990
VITA HI-CERAM
K902200 · EIH
Vident
Dental · 142d
Cleared Oct 05, 1990
RASTRONICS CCI 8
K902244 · ETW
Rastronics USA, Inc.
Ear, Nose, Throat · 140d
Cleared Oct 05, 1990
SMS-712NA
K903085 · GXW
Toshiba America Medical Systems, In.C
Neurology · 85d
Cleared Oct 05, 1990
LIQUID DETECTOR
K903495 · DXT
Life-Tech Intl., Inc.
Gastroenterology & Urology · 63d
Cleared Oct 05, 1990
TEMPOREX
K903551 · EBF
Scientific Pharmaceuticals, Inc.
Dental · 60d
Cleared Oct 05, 1990
MODEL TRITON 3000 BTE HEARING AID AND PMC SYSTEM
K903760 · ESD
Siemens Hearing Instruments, Inc.
Ear, Nose, Throat · 46d
Cleared Oct 05, 1990
MODEL 855 ENHANCED PERFORMANCE REMOTE TERMINAL
K904358 · HGM
Ge Medical Systems Information...
Obstetrics & Gynecology · 11d
Cleared Oct 04, 1990
V SET
K900336 · FPA
Go Medical Industries Pty. , Ltd.
General Hospital · 254d
Cleared Oct 04, 1990
DYNATRON 350 EMG/BIOFEEDBACK ANALYZER
K900639 · HCC
Dynatronics Laser Corp.
Neurology · 237d
Cleared Oct 04, 1990
CYSTICERCOSIS SEROLOGICAL REAGENTS
K900780 · MDJ
Lmd Laboratories
Microbiology · 226d