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
117745–117768 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 17, 1992
DSL ACTIVE SHBG (DSL 7400)
K915823 · CDZ
Diagnostic Systems Laboratories, Inc.
Chemistry · 78d
Cleared Mar 17, 1992
OPUS MYOGLOBIN TEST SYSTEM
K915850 · DDR
Pb Diagnostic Systems, Inc.
Immunology · 82d
Cleared Mar 17, 1992
B2-MICROGLOBULIN RADIOIMMUNOASSAY
K920300 · JZG
Nichols Institute
Immunology · 55d
Cleared Mar 17, 1992
ELECTROCARDIOGRAPH STRESS TEST FIRMWARE ACTAVIS
K920364 · DPS
Biosound, Inc.
Cardiovascular · 49d
Cleared Mar 17, 1992
INTERMEDICS MODEL 366-15 VS 1 HEADER PLUG
K920530 · DXY
Intermedics, Inc.
Cardiovascular · 41d
Cleared Mar 16, 1992
DISPOSABLE MONOPOLAR NEEDLE ELECTRODE, VAR MODELS
K912282 · IKT
Chalgren Enterprises, Inc.
Neurology · 293d
Cleared Mar 16, 1992
DETACHABLE, DISPOSABLE MONOPOLAR NEEDLE ELECTRODE
K912283 · IKT
Chalgren Enterprises, Inc.
Neurology · 298d
Cleared Mar 16, 1992
PERITONEAL DIALYSIS CYCLER SET
K914363 · KDI
National Medical Care, Medical...
Gastroenterology & Urology · 167d
Cleared Mar 16, 1992
DUAL BALLOON EMBOLECTOMY CATHETER
K914880 · DXE
Ideal Medical, Inc.
Cardiovascular · 138d
Cleared Mar 16, 1992
BASIC SET UP TRAY
K914928 · GEI
Westmark Hospital Supplies
General & Plastic Surgery · 133d
Cleared Mar 16, 1992
MRI ULTRAVIEW
K915260 · LNH
A&E Specialty Fabricators
Radiology · 118d
Cleared Mar 16, 1992
DEXTROLYTE II PERITONEAL DIALYSIS PUMP
K915628 · KDJ
National Medical Care, Medical...
Gastroenterology & Urology · 90d
Cleared Mar 16, 1992
16 BIT A/D
K915754 · LNH
Resonex, Inc.
Radiology · 84d
Cleared Mar 16, 1992
BREMER HALO SYSTEM CERVICAL TRACTION SKULL PIN
K915800 · JEC
Bremer Medical, Inc.
Orthopedic · 83d
Cleared Mar 16, 1992
MOS-III
K915873 · LNH
Sherman Ophthalmic Supplies, Inc.
Radiology · 102d
Cleared Mar 16, 1992
CLINICAL NEURO SYST MONITORR EXT CSF DRAIN/MONI SY
K920156 · JXG
Clinical Neuro Systems, LLC
Neurology · 62d
Cleared Mar 16, 1992
SCHNEIDER 8 FR. STAMINA(TM) GUIDING CATHETER
K920157 · DXY
Schneider Intl., Ltd.
Cardiovascular · 62d
Cleared Mar 13, 1992
KINESTHETICS MODEL 2000 NMS
K903870 · IPF
Kinesthetics, Inc.
Physical Medicine · 570d
Cleared Mar 13, 1992
LAPAROSCAN(TM) INTRAOPER DIAG ULTRASOUND SYSTEM
K913472 · ITX
Baxter Healthcare Corp
Radiology · 221d
Cleared Mar 13, 1992
OPTICA 25 ND:YAG DENTAL LASER SYSTEM
K913839 · GEX
Xintec Corporation
General & Plastic Surgery · 200d
Cleared Mar 13, 1992
SPECIFIC IGE EIA-TURBO ASSAY
K914554 · DHB
Ventrex Laboratories, Inc.
Immunology · 154d
Cleared Mar 13, 1992
MODELS C500/C550 ISOLETE(R) INFANT INCUBATOR
K914864 · FMZ
Air-Shields, Inc.
General Hospital · 136d
Cleared Mar 13, 1992
MODIFIED MAGNETIC RESONANCE IMAGING SYTEM MOD. R28
K915657 · LNH
Bruker Medical Imaging, Inc.
Radiology · 86d
Cleared Mar 13, 1992
D7113 ANVIL CUTTER AND D7112 AIR-POWERED HANDLE
K915745 · HQE
Storz Instrument Co.
Ophthalmic · 81d