Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
138625–138648 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 09, 1987
MODEL SSR1 HOLTER MONITOR
K873337 · DSH
Cardiodata Corp.
Cardiovascular · 51d
Cleared Oct 09, 1987
MEDIX BIOTECH PROLACTIN ENZYME IMMUNO. TEST KIT
K873355 · CFT
Medix Biotech, Inc.
Chemistry · 50d
Cleared Oct 09, 1987
MULTI-ACCESS REAGENT DISPENSER
K873416 · JQW
Electro-Nucleonics Laboratories, Inc.
Chemistry · 45d
Cleared Oct 09, 1987
KAWASUMI A.V. FISTULA SET
K873421 · FKQ
Kawasumi Laboratories Co., Ltd.
Gastroenterology & Urology · 45d
Cleared Oct 09, 1987
INTERMITTENT SIGNAL ACTUATED NEBULIZER (VISAN)
K873477 · CCQ
Vortran Medical Technology 1, Inc.
Anesthesiology · 39d
Cleared Oct 09, 1987
BSK-1033 TELEMETRY MONITORING CABLE
K873492 · DSA
Desco Industries, Inc.
Cardiovascular · 39d
Cleared Oct 09, 1987
PLAIN DRY GAUZE
K873523 · EFQ
Absorbent Cotton Co., Inc.
General & Plastic Surgery · 38d
Cleared Oct 09, 1987
MODIFIED MODELS 253-19 & 254-20 QUANTUM GENERATORS
K873528 · DXY
Intermedics, Inc.
Cardiovascular · 38d
Cleared Oct 09, 1987
ANGIOMAT CT INJECTOR
K873687 · DXT
Mallinckrodt Group, Inc.
Cardiovascular · 25d
Cleared Oct 09, 1987
FORTEC MI-100, MI-50 DIGITAL BLOOD PRESSURE METER
K873765 · DSK
Nam Tai , Ltd.
Cardiovascular · 23d
Cleared Oct 08, 1987
X-CALIBER MODEL 1000 BONE MINERAL ANALYZER
K871553 · KGI
Hologic, Inc.
Radiology · 169d
Cleared Oct 08, 1987
MAMMOGRAPH MAMMOGRAPHIC X-RAY DEVICE
K872734 · IZH
Palomex Instrumentarium Corp.
Radiology · 91d
Cleared Oct 08, 1987
PHADEBAS RAST/PHADEZYM RAST ALLERGEN DISCS
K873193 · DHB
Pharmacia, Inc.
Immunology · 56d
Cleared Oct 08, 1987
GLOBALCARE(TENS)
K873420 · GZJ
Oms Medico, Inc.
Neurology · 43d
Cleared Oct 08, 1987
COL. CNA 5% SB/MACCONKEY AGAR BIPLATE # Z3206
K873479 · JSJ
Lakewood Biochemical Co., Inc.
Microbiology · 42d
Cleared Oct 08, 1987
TSA 5% SHEEP BLOOD/EMB AGAR - PRODUCT #Z3023
K873480 · JSG
Lakewood Biochemical Co., Inc.
Microbiology · 42d
Cleared Oct 08, 1987
HEKTOEN ENTERIC (HE) AGAR/XLD AGAR BIPLATE #Z3016
K873481 · JSI
Lakewood Biochemical Co., Inc.
Microbiology · 42d
Cleared Oct 08, 1987
TSA 5% SHEEP BLOOD (SB)/MACCONKEY AGAR #Z3033
K873482 · JSG
Lakewood Biochemical Co., Inc.
Microbiology · 42d
Cleared Oct 08, 1987
TSA 5% SHEEP BLOOD (SB)/LEVINE EMB AGAR #Z3020
K873483 · JSG
Lakewood Biochemical Co., Inc.
Microbiology · 42d
Cleared Oct 08, 1987
PEDIATRIC BELLOWS
K873549 · CBK
Draeger Medical, Inc.
Anesthesiology · 38d
Cleared Oct 08, 1987
DIGIVIEWER
K873646 · LLZ
Digivision, Inc.
Radiology · 30d
Cleared Oct 08, 1987
BAHIA ALLERGEN DISC
K873648 · DHB
Incstar Corp.
Immunology · 29d
Cleared Oct 08, 1987
MYCOLOGY W/CYCLOHEXANIDE & CHLORAMPHEMICOL (C&C)
K873827 · JSJ
Lakewood Biochemical Co., Inc.
Microbiology · 17d
Cleared Oct 07, 1987
PULSE-OX
K863857 · DQA
Life Design Systems, Inc.
Anesthesiology · 370d