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
90865–90888 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 10, 1998
BYRON MEDICAL ASPIRATION AND INFILTRATION/IRRIGATION TUBING
K974295 · KGZ
Byron Medical
General & Plastic Surgery · 88d
Cleared Feb 10, 1998
LATEX CONDOMS NATURAL COLOUR WITH SILICONE OIL LUBRICANT
K974323 · HIS
Reddy Medtech Health Products , Ltd.
Obstetrics & Gynecology · 84d
Cleared Feb 10, 1998
BALDUR NON-STERILE COTTON SPONGES
K974347 · EFQ
Baldur Systems Corp.
General & Plastic Surgery · 83d
Cleared Feb 10, 1998
FRIALIT -2 SCREW
K974358 · DZE
Friatec AG
Dental · 83d
Cleared Feb 10, 1998
FRIALIT-2 CYLINDER
K974359 · DZE
Friatec AG
Dental · 83d
Cleared Feb 10, 1998
CANDELA GENTLELASE GL DERMATOLOGICAL LASER
K974381 · GEX
Candela Corp.
General & Plastic Surgery · 82d
Cleared Feb 10, 1998
STERILE SALINE FOR CATHETER CARE
K974397 · JOL
Baxter Healthcare Corp
General Hospital · 81d
Cleared Feb 10, 1998
ISOLATED ELECTROSURGICAL PROBES AND DEVICES-SALINETRODE
K974484 · GEI
Ximed/Prosure/Injectx
General & Plastic Surgery · 76d
Cleared Feb 10, 1998
RENAMEL FLOWABLE COMPOSITE
K974494 · EBD
Cosmedent, Inc.
Dental · 74d
Cleared Feb 10, 1998
L-CATH MODIFIED SELDINGER TECHNIQUE INSERTION/CATHETER EXCHANGE KIT...
K974543 · FOZ
Luther Medical Products, Inc.
General Hospital · 69d
Cleared Feb 10, 1998
DENTAL D
K974622 · EHP
Micro Dental Laboratories
Dental · 61d
Cleared Feb 10, 1998
O.B. APPLICATOR AND NON-APPLICATOR TAMPONS
K974629 · HEB
Personal Products Co.
Obstetrics & Gynecology · 60d
Cleared Feb 10, 1998
UFI GEL C
K974772 · EBI
Voco GmbH
Dental · 50d
Cleared Feb 10, 1998
ACCURUN(TM) 150 HSV IGG POSITIVE CONTROL
K974811 · JJX
Boston Biomedica, Inc.
Microbiology · 49d
Cleared Feb 09, 1998
ELASTYREN POWDER-FREE SURGICAL GLOVE
K971471 · KGO
Eci Medical Technologies, Inc.
General Hospital · 292d
Cleared Feb 09, 1998
PRE-LOADED REPLACEMENT G-TUBES AND ACCESSORIES
K972478 · KNT
Applied Medical Technologies
Gastroenterology & Urology · 223d
Cleared Feb 09, 1998
COMPOSITE 168 RESTORATIVE SYSTEM
K973221 · EBF
Dentsply Intl.
Dental · 166d
Cleared Feb 09, 1998
BIO-RAD MICROPLATE 17-HYDROXYPROGESTERONE TEST
K973350 · JLX
Bio-Rad
Chemistry · 157d
Cleared Feb 09, 1998
UBI MAGIWEL C-REACTIVE PROTEIN(CRP) QUANTITATIVE
K973692 · DCK
United Biotech, Inc.
Immunology · 136d
Cleared Feb 09, 1998
AIRIS II
K974212 · LNH
Hitachi Medical Systems America, Inc.
Radiology · 91d
Cleared Feb 09, 1998
LATEX CONDOMS COLOUR WITH SPERMICIDAL LUBRICANT
K974324 · LTZ
Reddy Medtech Health Products , Ltd.
Obstetrics & Gynecology · 83d
Cleared Feb 09, 1998
LATEX CONDOMS (NATURAL COLOUR)
K974326 · LTZ
Reddy Medtech Health Products , Ltd.
Obstetrics & Gynecology · 83d
Cleared Feb 09, 1998
ALLERGAN IMMUNO CAP M4, M8, K70
K974350 · DHB
Pharmacia, Inc.
Immunology · 82d
Cleared Feb 09, 1998
ULTRAGUIDE 1000
K974432 · IYO
Ultraguide , Ltd.
Radiology · 77d