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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
138025–138048 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 09, 1987
LOW PROFILE GASTROSTOMY
K872771 · KNT
Microvasive
Gastroenterology & Urology · 87d
Cleared Oct 09, 1987
MACTRODE-II
K872784 · DRX
Marquette Electronics, Inc.
Cardiovascular · 87d
Cleared Oct 09, 1987
DP-700 NIKMAN DEFIB-PADS
K872793 · LDD
Nikomed U.S.A., Inc.
Cardiovascular · 87d
Cleared Oct 09, 1987
NOVOLINPEN DIAL-A-DOSE INSULIN DELIVERY SYSTEM
K872805 · FMF
Squibb-Novo, Inc.
General Hospital · 86d
Cleared Oct 09, 1987
PARAGON 8500 CARDIO-PULMONARY BED
K872924 · FNL
Surgi-Med, Inc.
General Hospital · 74d
Cleared Oct 09, 1987
DAVOL INTRAOPERATIVE AUTOTRANSFUSION KIT
K872927 · CAC
C.R. Bard, Inc.
Anesthesiology · 74d
Cleared Oct 09, 1987
MODEL NUMBER 9216 RESPIRATION/HEART RATE MONITOR
K872954 · BZQ
Aequitron Medical, Inc.
Anesthesiology · 72d
Cleared Oct 09, 1987
CONFORMA(TM) PLASTER BANDAGES
K873111 · ITG
The Kendal Co.
Physical Medicine · 60d
Cleared Oct 09, 1987
STRETCHER, WHEELED, MECHANICAL
K873181 · FPO
Cambridge Technologies, Inc.
General Hospital · 58d
Cleared Oct 09, 1987
ENHANCE SUPPORT HOSE
K873280 · DWL
Kimberly-Clark Corp.
General Hospital · 53d
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