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
90361–90384 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Feb 09, 1998
IMMUNO CONCEPTS ANCA TEST SYSTEM
K974463 · MOB
Immuno Concepts, Inc.
Immunology · 75d
Cleared Feb 09, 1998
IMMUNO CONCEPTS ANCA TEST SYSTEMS
K974478 · MOB
Immuno Concepts, Inc.
Immunology · 75d
Cleared Feb 09, 1998
NTL-FLOW
K974483 · EBF
Bisco, Inc.
Dental · 75d
Cleared Feb 09, 1998
MODIFIED URETERAL INDWELLING CATHETER/STENT
K974541 · FAD
Boston Scientific Corp
Gastroenterology & Urology · 68d
Cleared Feb 09, 1998
ALLERGEN IMMUNOCAP F256,F245,F207,F202
K974580 · DHB
Pharmacia & Upjohn Co.
Immunology · 63d
Cleared Feb 09, 1998
ENCORE MARK IV POWDER FREE SURGICAL GLOVES
K974783 · KGO
Ansell Perry
General Hospital · 49d
Cleared Feb 09, 1998
LATEX (POWDER FREE) LOW PROTEIN
K974853 · LYY
P.T. Healthcare Glovindo
General Hospital · 42d
Cleared Feb 09, 1998
POWDERFREE GREEN LATEX EXAMINATION GLOVES (POLYMER COATED)
K980037 · LYY
Sri Johani Sdn. Bhd.
General Hospital · 35d
Cleared Feb 09, 1998
POWDERFREE GREEN LATEX EXAMINATION GLOVES
K980038 · LYY
Sri Johani Sdn. Bhd.
General Hospital · 35d