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
140377–140400 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 17, 1987
SS-DNA EIA DIAGNOSTIC KIT
K870452 · LJM
Biohytech International, Inc.
Immunology · 55d
Cleared Mar 17, 1987
SM EIA DIAGNOSTIC KIT
K870455 · LJM
Biohytech International, Inc.
Immunology · 55d
Cleared Mar 17, 1987
DNP EIA DIAGNOSTIC KIT
K870456 · LJM
Biohytech International, Inc.
Immunology · 55d
Cleared Mar 17, 1987
RNP EIA DIAGNOSTIC KIT
K870457 · LJM
Biohytech International, Inc.
Immunology · 55d
Cleared Mar 17, 1987
HISTONES EIA DIAGNOSTIC KIT
K870458 · DHN
Biohytech International, Inc.
Immunology · 55d
Cleared Mar 17, 1987
NEU-PULS(TENS) MODEL #295
K870583 · GZJ
Oms Medico, Inc.
Neurology · 34d
Cleared Mar 17, 1987
AIRLIFE ARTERIAL BLOOD GAS SAMPLING SYRINGE
K870720 · CBT
American Pharmaseal Div. Ahsc
Anesthesiology · 25d
Cleared Mar 17, 1987
KEELER PULSAIR NON CONTACT TONOMETER
K870750 · HKX
Keeler Instruments, Inc.
Ophthalmic · 20d
Cleared Mar 17, 1987
THE (CROM) TESTER
K870767 · KQW
Twin City Surgical, Inc.
Neurology · 19d
Cleared Mar 17, 1987
AZTREONAM 30 MCG SUSCEPTIBILITY DISK
K870870 · JTN
Organon Teknika Corp.
Microbiology · 14d
Cleared Mar 17, 1987
WARM WEIGH MODEL N-10 INFANT SCALE
K870888 · FRW
Air-Shields, Inc.
General Hospital · 12d
Cleared Mar 17, 1987
T-CONNECTORS 014500/014501/014502/014503-120
K870912 · FPK
Clinical Connections, Inc.
General Hospital · 11d
Cleared Mar 17, 1987
INJECTION SITE #014456-120
K870913 · FPA
Clinical Connections, Inc.
General Hospital · 11d
Cleared Mar 17, 1987
PAD, BED LINEN PROTECTIVE
K870925 · KME
Quality Disposables, Inc.
General Hospital · 8d
Cleared Mar 17, 1987
SOLUTION ADMINI. SETS- ALTER. DRIP CHAMBER/CONNEC.
K870940 · FPA
Travenol Laboratories, S.A.
General Hospital · 8d
Cleared Mar 17, 1987
COAG-A-MATE(R) XC
K870960 · JPA
Organon Teknika Corp.
Hematology · 7d
Cleared Mar 16, 1987
COCAINE METABOLITE ROCHE(R) EIA
K863843 · DIO
Roche Diagnostic Systems, Inc.
Toxicology · 166d
Cleared Mar 16, 1987
VISION(TM) CRP
K864131 · DCK
Abbott Laboratories
Immunology · 146d
Cleared Mar 16, 1987
MORPHINE ROCHE (R) EIA TEST
K864168 · DOE
Roche Diagnostic Systems, Inc.
Toxicology · 143d
Cleared Mar 16, 1987
ARGYLE SENTINEL SEAL AUTOTRANSFUSION SYSTEM
K864374 · CAC
Sherwood Medical Co.
Anesthesiology · 131d
Cleared Mar 16, 1987
LIFEWATCH(R) PORTABLE MONITORING SYSTEM
K864419 · BZQ
Lifewatch Systems, Inc.
Anesthesiology · 126d
Cleared Mar 16, 1987
STAVIP 3000
K864436 · JJN
Roseburg SA
Chemistry · 124d
Cleared Mar 16, 1987
PFLEX EM(TM) (EXERCISE MONITOR)
K864719 · BWF
Health Products, Inc.
Anesthesiology · 103d
Cleared Mar 16, 1987
HORIZON 1100 CARDIAC MONITOR
K864843 · DPS
Mennen Medical, Inc.
Cardiovascular · 96d