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
94945–94968 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 25, 1997
RESPIFLO/S
K962874 · CAF
Curtin & Associates International , Inc.
Anesthesiology · 217d
Cleared Feb 25, 1997
CAPIOX SP PUMP HEAD
K962981 · KFM
Terumo Medical Corp.
Cardiovascular · 208d
Cleared Feb 25, 1997
GENZYME DIAGNOSTICS CONTRAST MONO
K963425 · KTN
Genzyme Diagnostics
Immunology · 179d
Cleared Feb 25, 1997
MASK SURGICAL
K963568 · FXX
The Innovative Approach, Corp.
General Hospital · 173d
Cleared Feb 25, 1997
EZTEST
K963841 · FRC
Sgm Biotech, Inc.
General Hospital · 153d
Cleared Feb 25, 1997
HOLDEN-WALKER HUMIDIFIER-NEBULIZER KIT
K963917 · CAF
Holden Walker Corp.
Anesthesiology · 148d
Cleared Feb 25, 1997
ENDOCARE CRYOCARE CRYOSURGICAL SYSTEM URETHRAL WARMING SYSTEM
K963970 · GEH
Endocare, Inc.
General & Plastic Surgery · 145d
Cleared Feb 25, 1997
MEDLINE DISPOSABLE SURGICAL DRAPES AND GOWNS
K964142 · KKX
Medline Industries, Inc.
General Hospital · 132d
Cleared Feb 25, 1997
DISPOSABLE APRON
K964364 · LYU
Instrument Makar, Inc.
General Hospital · 116d
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