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
115177–115200 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 03, 1992
MAXXUS
K924498 · KPS
GE Medical Systems
Radiology · 90d
Cleared Dec 03, 1992
CAPTUS 500 WELL DETECTOR W/CLINICAL LABOR SOFTWARE
K924586 · IZD
Capintec Instruments, Inc.
Radiology · 84d
Cleared Dec 03, 1992
OLYMPUS GLUCOSE REAGENT
K924601 · CFR
Olympus Corp.
Chemistry · 83d
Cleared Dec 03, 1992
BICARBONATE
K924711 · KHS
Em Diagnostic Systems, Inc.
Hematology · 76d
Cleared Dec 03, 1992
DMI BLOOD GAS ANALYZER/CARTRIDGE
K924758 · CHL
Diamond Medical, Inc.
Chemistry · 71d
Cleared Dec 03, 1992
OLYMPUS TOTAL BILIRUBIN REAGENT
K924964 · CIG
Olympus Corp.
Chemistry · 64d
Cleared Dec 03, 1992
COBAS-FP REAGENT FOR VALPROIC ACID AND CALIBRATORS
K925003 · LEG
Roche Diagnostic Systems, Inc.
Toxicology · 62d
Cleared Dec 03, 1992
REMEL ENOXACIN 10 MCG SUSCEPTIBILITY DISK
K925060 · JTN
Remel Co.
Microbiology · 58d
Cleared Dec 03, 1992
SHIMADZU RADIOGRAPJHIC STAND BR-100
K925169 · KPX
Shimadzu Medical Systems
Radiology · 51d
Cleared Dec 03, 1992
CMI STOMA COVERS
K925249 · BTO
Community Medical Center
Anesthesiology · 48d
Cleared Dec 03, 1992
QUICKVUE ONE-STEP HCG TEST
K925435 · JHI
Quidel Corp.
Chemistry · 36d
Cleared Dec 02, 1992
SENSORMEDICS MODEL 2600 PEDIATRIC PULMOONARY CART
K915833 · BZC
Sensor Medics Corp.
Anesthesiology · 344d
Cleared Dec 02, 1992
ANGIOGRAPHIC X-RAY SYSTEM
K922222 · IZI
Siemens Medical Solutions USA, Inc.
Radiology · 204d
Cleared Dec 01, 1992
MODIFICATION MANUAL PULMON RESUSCITOR/PULMANEX(TM)
K913714 · BTM
Life Design Systems, Inc.
Anesthesiology · 474d
Cleared Dec 01, 1992
MODEL 2900 METABOLIC MEASUREMENT CART
K915686 · BZC
Sensor Medics Corp.
Anesthesiology · 347d
Cleared Dec 01, 1992
SYN ELISA DSDNA ANTIBODIES
K921132 · LKJ
Elias U.S.A., Inc.
Immunology · 266d
Cleared Dec 01, 1992
ENCORE SM
K921572 · LLL
Clark Laboratories, Inc.
Immunology · 243d
Cleared Dec 01, 1992
ENCORE SM/RNP
K921870 · LLL
Clark Laboratories, Inc.
Immunology · 225d
Cleared Dec 01, 1992
MODEL #510 STEALTH-PLATE DISPERSIVE ELECTRODE
K922064 · GXD
Cardiotronics, Inc.
Neurology · 211d
Cleared Dec 01, 1992
NEBULIZER SYSTEM
K922623 · BTI
Healthdyne, Inc.
Anesthesiology · 182d
Cleared Dec 01, 1992
VENTILATOR ADULT STAR MODIFICATION
K922654 · CBK
Infrasonics Corp.
Anesthesiology · 181d
Cleared Dec 01, 1992
PULSE CRP TEST
K923768 · DCK
Pulse Scientific, Inc.
Immunology · 126d
Cleared Dec 01, 1992
ACCUTEX RHEUMATIOD FACTOR (RF) LATEX TEST
K924036 · DHR
J.S. Medical Assoc.
Immunology · 112d
Cleared Dec 01, 1992
VENTREX ALLERGEN DISC
K924044 · DHB
Hycor Biomedical, Inc.
Immunology · 112d