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
94441–94464 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 25, 1997
PERFECTIM
K964692 · ELW
J. Morita USA, Inc.
Dental · 95d
Cleared Feb 25, 1997
THREADLOC DENTAL IMPLANT SYSTEMS
K964768 · DZE
Sulzer Calcitek, Inc.
Dental · 90d
Cleared Feb 25, 1997
MEDRAD CONTRAST HOLDER
K964782 · FOX
Medrad, Inc.
General Hospital · 90d
Cleared Feb 25, 1997
SOLUTION ADMINISTRATION SET WITH 0.22 MICRON HIGH PRESSURE EXTENDED LIFE FILTER
K964850 · FPA
Baxter Healthcare Corp
General Hospital · 84d
Cleared Feb 25, 1997
SUTURE LOCK
K964935 · KGS
Smith & Nephew Endoscopy, Inc.
General & Plastic Surgery · 77d
Cleared Feb 25, 1997
SUNGLASSES (NON-PRESCRIPTION)
K964943 · HQY
Micron Eyewear Manufactory Co., Ltd.
Ophthalmic · 77d
Cleared Feb 25, 1997
NON-PRESCRIPTION SUNGLASSES
K965021 · HQY
Victory Eyewear Co., Ltd.
Ophthalmic · 71d
Cleared Feb 25, 1997
ENDOCARE MONOPOLAR ELECTRODE
K965118 · FAS
Endocare, Inc.
Gastroenterology & Urology · 67d
Cleared Feb 25, 1997
LIFECORE CONICAL ABUTMENT
K965135 · DZE
Lifecore Biomedical, Inc.
Dental · 64d
Cleared Feb 25, 1997
ENDOCARE ELECTROSURGICAL ELECTRODE
K965243 · GEI
Endocare, Inc.
General & Plastic Surgery · 64d
Cleared Feb 25, 1997
ACCESS ESTRADIOL REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER (33550,33540,33545)
K970126 · CHP
Bio-Rad Laboratories, Inc.
Chemistry · 42d
Cleared Feb 25, 1997
VITROS IMMUNODIAGNOSTIC PRODUCTS PROLACTIN REAGENT PACK/CALIBRATORS
K970281 · CFT
Johnson & Johnson Clinical...
Chemistry · 32d
Cleared Feb 25, 1997
OMNI GRIP LATEX EXAMINATION GLOVE, POWDER-FREE
K970297 · LYY
Omni Sales Corp.
General Hospital · 29d
Cleared Feb 25, 1997
HOLLISTER RETRACTED PENIS POUCH
K970443 · EXI
Hollister, Inc.
Gastroenterology & Urology · 20d
Cleared Feb 24, 1997
CHLAMYDIA IGG ELISA TEST SYSTEM
K962558 · LJC
Armkel, LLC
Microbiology · 238d
Cleared Feb 24, 1997
ALARM DISPLAY UNIT/PAGER-LAN SYSTEM (ADU)
K962827 · DSI
Marquette Electronics, Inc.
Cardiovascular · 220d
Cleared Feb 24, 1997
CARETONE II
K963678 · DQD
American Telecare, Inc.
Cardiovascular · 164d
Cleared Feb 24, 1997
MITEK ABSORBABLE TOGGLE ANCHOR
K964013 · MAI
Mitek Products
Orthopedic · 140d
Cleared Feb 24, 1997
KINEMATIC POSITIONING DEVICES
K964752 · LNH
Philips Medical Systems (Cleveland),...
Radiology · 89d
Cleared Feb 24, 1997
HI-STAR MRI IMAGING SYSTEM
K964778 · LNH
Health Images, Inc.
Radiology · 89d
Cleared Feb 24, 1997
INNOVASIVE DEVICES ROTATOR CUFF FASTNER
K964945 · MBI
Innovasive Devices, Inc.
Orthopedic · 76d
Cleared Feb 24, 1997
KINEMAX PLUS TIBIAL SPACERS
K964951 · JWH
Howmedica Corp.
Orthopedic · 76d
Cleared Feb 24, 1997
INTERMITTENT COMPRESSOR SYSTEM
K964957 · IRP
Eischoco, Inc.
Physical Medicine · 75d
Cleared Feb 24, 1997
COHORT DISCECTOMY SYSTEMS (CDS)
K964975 · HRX
Cohort Medical Products Group, Inc.
Orthopedic · 74d