FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
121681–121704 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 21, 1991
SOFT HYDROXYLAPATITE OSSICULAR MALLEABLE PROSTHES
K904239 · ETA
Microbio-Medics, Inc.
Ear, Nose, Throat · 281d
Cleared Jun 21, 1991
EURO-DIAGNOSTIC BLOOD PRESSURE MONITOR
K904298 · DXN
Medi-Swiss Corp.
Cardiovascular · 275d
Cleared Jun 21, 1991
AGFA DIAGNOSTIC CENTER (ADC)
K904519 · LLZ
Enhanced Imaging Technologies, Inc.
Radiology · 261d
Cleared Jun 21, 1991
NDI MODEL IRS-TD
K904676 · KPR
National Diagnostic Imaging, Inc.
Radiology · 252d
Cleared Jun 21, 1991
MICRODELTA, TC-99M-MAG3 RENAL PROCESSING PROGRAM
K905074 · IYX
Siemens Gammasonics, Inc.
Radiology · 224d
Cleared Jun 21, 1991
4.5F IMAGECATH ANGIOSCOPE
K905083 · LYK
Baxter Healthcare Corp
Cardiovascular · 220d
Cleared Jun 21, 1991
BERLEX BOLUS/INFUSION(TM) INTRAVENOUS ADMIN SET
K905518 · IZI
Venusa , Ltd.
Radiology · 196d
Cleared Jun 21, 1991
AGARRELIEF 10 TRANSCUTANEOUS ELEC NERVE STIMULATOR
K905526 · GZJ
Agar Ginosar Electronics
Neurology · 193d
Cleared Jun 21, 1991
FIXATION DEVICES AND BONE PLATE
K910175 · HRS
Micro Surgical Instruments Corp.
Orthopedic · 157d
Cleared Jun 21, 1991
PCA MTK II TOTAL KNEE SYSTEM
K910235 · JWH
Howmedica Corp.
Orthopedic · 154d
Cleared Jun 21, 1991
BIOCLONE'S ELEGANCE IGE ELISA KIT
K910419 · DGC
Bioclone Australia Pty , Ltd.
Immunology · 142d
Cleared Jun 21, 1991
ABUSCREEN FP FOR CANNABINOIDS (15-50)
K910592 · LDJ
Roche Diagnostic Systems, Inc.
Toxicology · 129d
Cleared Jun 21, 1991
MEHIGAN-PILLING PHLEBETOME TM
K911100 · MGZ
Pilling Co.
Cardiovascular · 101d
Cleared Jun 21, 1991
RIGID ENDOSCOPE
K911348 · LNH
Bruel & Kjaer
Radiology · 86d
Cleared Jun 21, 1991
ISOLA(TM) SPINE SYSTEM--EYE ROD
K911394 · KWP
Acromed Corp.
Orthopedic · 84d
Cleared Jun 21, 1991
MAGNETIC RESONANCE DEVICE ACCESSORY (MRT-50A)
K911495 · LNH
Toshiba America Mri, Inc.
Radiology · 78d
Cleared Jun 21, 1991
SYRINGE TIP CAP
K911638 · JKA
Concord/Portex
Chemistry · 71d
Cleared Jun 21, 1991
ECG FEMALE-TO-PIN SNAP ELECTRODE W/LEADS AND EXT.
K911990 · DRX
Somnitec, Inc.
Cardiovascular · 46d
Cleared Jun 20, 1991
MODIFIED MODELS 2000W AND 2000W OPTION H APNEA MON
K905575 · BZQ
Edentec Corp.
Anesthesiology · 190d
Cleared Jun 20, 1991
MEGA LUMBAR PUNCTURE KIT
K910089 · FMJ
Megadyne Medical Products, Inc.
General Hospital · 162d
Cleared Jun 20, 1991
MICROSTIM 100 MODEL 2C
K910580 · GZJ
Microstim, Inc.
Neurology · 129d
Cleared Jun 20, 1991
MEDISYSTEMS HEMODIALYSIS FISTULA SET
K910734 · FIE
Medisystems Corp.
Gastroenterology & Urology · 119d
Cleared Jun 20, 1991
THOROCENTESIS KIT
K910963 · JOL
Megadyne Medical Products, Inc.
General Hospital · 106d
Cleared Jun 20, 1991
DISPOSABLE SPECIMEN BAG W/CANNULA AND INTRODUCER
K911262 · GEA
Ethicon, Inc.
General & Plastic Surgery · 90d