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
126049–126072 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 28, 1990
INTRASITE CAVITY WOUND DRESSING (LABEL REVISION)
K901876 · KOZ
Smith & Nephew United, Inc.
General & Plastic Surgery · 63d
Cleared Jun 28, 1990
HELIO PROGRESS (DENTAL COMPOSITE)
K901914 · EBF
Ivoclar North America, Inc.
Dental · 63d
Cleared Jun 28, 1990
DUAL CEMENT
K901917 · EBF
Ivoclar North America, Inc.
Dental · 63d
Cleared Jun 28, 1990
COAT-A-COUNT PAP IRMA, CATLOG# 1KPA1, 1KPA2
K901933 · JFH
Diagnostic Products Corp.
Chemistry · 59d
Cleared Jun 28, 1990
MOBILE MRP-20 MAGNETIC RESONANCE DIAGNOSTIC DEVICE
K901980 · LNH
Summit World Trade Corp.
Radiology · 57d
Cleared Jun 28, 1990
KODAK SURECELL(TM) HCG-URINE TEST KIT
K902136 · JHI
Eastman Kodak Company
Chemistry · 49d
Cleared Jun 28, 1990
COULTER CREATININE REAGENT
K902172 · CGX
Coulter Corp.
Chemistry · 45d
Cleared Jun 28, 1990
HI CHEM ENZYME LINEARITY STANDARDS (PROD. 88235)
K902321 · JJT
Hichem Diagnostics
Chemistry · 36d
Cleared Jun 28, 1990
SYNERMED TOTAL BILIRUBIN REAGENT KIT
K902328 · CIG
Synermed, Inc.
Chemistry · 35d
Cleared Jun 28, 1990
SILVER-FREE CERAMIC SOLDER (SFCS)
K902372 · EJT
Leach and Dillon Co., Inc.
Dental · 30d
Cleared Jun 28, 1990
200 SILHOUETTE LINE (SL) CERAMIC SOLDER
K902373 · EJT
Leach and Dillon Co., Inc.
Dental · 30d
Cleared Jun 28, 1990
DW231 DENTAL ALLOY
K902376 · EJS
Ivoclar North America, Inc.
Dental · 30d
Cleared Jun 28, 1990
DEGUSSA STOPFGOLD (DEGUSSA DIRECT-FILLING GOLD)
K902387 · EJT
Degussa AG
Dental · 29d
Cleared Jun 28, 1990
DENTAL-QUECKSILBER (DENTAL MERCURY)
K902388 · ELY
Degussa AG
Dental · 29d
Cleared Jun 28, 1990
CIBA CORNING MAGIC LITE LH IMMUNOASSAY
K902398 · CEP
Ciba Corning Diagnostics Corp.
Chemistry · 29d
Cleared Jun 28, 1990
MONO-LEX SYSTEM: INFECTIOUS MONONUCLEOSIS LATEX
K902541 · KTN
Trinity Laboratories, Inc.
Immunology · 22d
Cleared Jun 28, 1990
RAICHEM(TM) SPIA(TM) CRP REAGENT
K902593 · DCN
Reagents Applications, Inc.
Immunology · 16d
Cleared Jun 28, 1990
LIPOGEN RHEUMELISA DSDNA ASSAY
K902636 · LRY
Lipogen, Inc.
Immunology · 14d
Cleared Jun 27, 1990
MAXX 470 CORE BIOPSY GUN
K900082 · KNW
Dlp, Inc.
Gastroenterology & Urology · 173d
Cleared Jun 27, 1990
GAMASHIELD
K900298 · KGO
Formtex Medical Sdn. Bhd.
General Hospital · 155d
Cleared Jun 27, 1990
LYNX LOW-SPEED HANDPIECE
K900798 · EFB
Air Motors Technologies
Dental · 127d
Cleared Jun 27, 1990
EXTERNAL LEG BAG
K901219 · FAQ
Orion Life Systems, Inc.
Gastroenterology & Urology · 106d
Cleared Jun 27, 1990
700 ULTREX PENILE PROSTHESIS 12MM DIAMETER
K901482 · FAE
American Medical Systems, Inc.
Gastroenterology & Urology · 90d
Cleared Jun 27, 1990
FITC MURINE MONOCLONAL ANTI-INFLUENZA TYPE B
K901493 · GNX
Whittaker Bioproducts, Inc.
Microbiology · 90d