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
90745–90768 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 05, 1998
PRIMUS HOLLOW FIBER DIALYZER (MODELS 1000,1000S,1350,1350S,2000,2000S)
K970648 · MSF
Renal Systems, Inc.
Gastroenterology & Urology · 319d
Cleared Jan 05, 1998
INCUWARMER
K971366 · FMT
Hill-Rom, Inc.
General Hospital · 266d
Cleared Jan 05, 1998
NPG + 2
K972971 · EJH
Aalba Dent, Inc.
Dental · 147d
Cleared Jan 05, 1998
DRG LARGE SCREW SYSTEM
K973810 · HWC
Dolphin Medical Technologies, Inc.
Orthopedic · 90d
Cleared Jan 05, 1998
PRIMA KTP LASER SYSTEM
K973828 · GEX
Nidek, Inc.
General & Plastic Surgery · 90d
Cleared Jan 05, 1998
CORDIS HYDRONOL STEERABLE GUIDEWIRE
K973845 · DQX
Cordis Corp.
Cardiovascular · 89d
Cleared Jan 05, 1998
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY #M12/630
K973851 · FRN
Alexander Mfg. Co.
General Hospital · 89d
Cleared Jan 05, 1998
O BUTMENT HS IMPLANT
K973926 · DZE
"O" Co., Inc.
Dental · 82d
Cleared Jan 05, 1998
ADHESIVE HYBRID IONOMER CEMENT
K974140 · EMA
Dentsply Intl.
Dental · 63d
Cleared Jan 05, 1998
PRE-POWDERED NITRILE EXAMINATION GLOVES
K974442 · LZY
P.T. Latexindo Tobaperkasa
Orthopedic · 41d
Cleared Jan 05, 1998
POWDER FREE NITRILE EXAMINATION GLOVES - POLYMER COATED
K974443 · LYZ
P.T. Latexindo Tobaperkasa
General Hospital · 41d
Cleared Jan 05, 1998
FANFOLD DRAPE 41 X 57 PRODUCT NO. 900-633, RECORDER NO. 0633
K974647 · KKX
Customed, Inc.
General Hospital · 24d
Cleared Jan 02, 1998
TANGO NON-INVASIVE BLOOD PRESSURE MONITOR
K970629 · DXN
Suntech Medical Instruments, Inc.
Cardiovascular · 317d
Cleared Jan 02, 1998
QUANTA LITE REBELLA IGG
K971304 · LFX
Inova Diagnostics, Inc.
Microbiology · 269d
Cleared Jan 02, 1998
GLUCOCHEK POCKETLAB II BLOOD GLUCOSE SYSTEM
K971653 · CGA
Clinical Diagnostics, Inc.
Chemistry · 241d
Cleared Jan 02, 1998
BARCO MWD 321 MEDICAL WORKSTATION DISPLAY
K972701 · LMD
Barco NV Display Systems
Radiology · 168d
Cleared Jan 02, 1998
SPIFE IFE-6
K973040 · CFF
Helena Laboratories
Chemistry · 141d
Cleared Jan 02, 1998
CHROMALEX E. COLI 0157 LATEX TEST SYSTEM, PROD. NO. 800
K973457 · GMZ
Shared Systems, Inc.
Microbiology · 112d
Cleared Jan 02, 1998
STC COCAINE METABOLITE MICRO-PLATE EIA
K973651 · DIO
OraSure Technologies, Inc.
Toxicology · 99d
Cleared Jan 02, 1998
NORTHWEST RADIATION THERAPY PRODUCTS, PRECISION STEPPER AND GUIDE
K973786 · IWJ
Nw Radiation Therapy Products
Radiology · 88d
Cleared Jan 02, 1998
S-57 VIDEO IMAGING SYSTEM
K973794 · GCJ
Sopro
General & Plastic Surgery · 88d
Cleared Jan 02, 1998
S-52 ELECTRONIC VIDEO LAPAROSCOPE
K973795 · GCJ
Sopro
General & Plastic Surgery · 88d
Cleared Jan 02, 1998
S-41 &41S VIDEO IMAGING SYSTEM
K973796 · GCJ
Sopro
General & Plastic Surgery · 88d
Cleared Jan 02, 1998
CARDIAC TAGGING TECHNIQUES/MAGNETOM VISION AND MAGNETOM IMPACT
K973799 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 88d