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
124153–124176 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 20, 1990
AUTOMATED DISPOSABLE SOFT TISSUE BIOPSY ASPIR. DEV
K904658 · KNW
Leigh Med Tech, Inc.
Gastroenterology & Urology · 36d
Cleared Nov 20, 1990
ENZYMATIC BILIRUBIN (TOTAL), CATALOGUE NO. 202-14
K904660 · JFM
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 36d
Cleared Nov 20, 1990
S-ROM(TM) FEMORAL STEM CENTRALIZER/CEMENT SPACER
K904746 · JDK
Joint Medical Products Corp.
Orthopedic · 33d
Cleared Nov 20, 1990
P/N 35310, IL TEST ALKALINE PHOSPHATASE REAGENT
K904761 · CIE
Instrumentation Laboratory CO
Chemistry · 32d
Cleared Nov 20, 1990
EMIT (R) II CALIBRATOR A LEVEL 1 (CUTOFF) 2 (HIGH)
K904764 · DKB
Syva Co.
Toxicology · 29d
Cleared Nov 20, 1990
CEDIA (R) VITAMIN B12/FOLATE ASSAY
K904776 · CDD
Microgenics Corp.
Chemistry · 29d
Cleared Nov 20, 1990
ORION PLUS/MODIFICATION
K904840 · HIS
Mayer Laboratories
Obstetrics & Gynecology · 27d
Cleared Nov 20, 1990
MODEL 400 ULTRA COMPACT VIDEO IMAGER
K904897 · LMC
International Imaging Electronics
Radiology · 22d
Cleared Nov 20, 1990
SCHRADER OXYGEN/AIR VAC&NITR-OXIDE MALE QUICK CONN
K905094 · BYX
Medical Fittings, Inc.
Anesthesiology · 7d
Cleared Nov 19, 1990
WILSON-COOK PULL THROUGH PEG KIT
K901163 · FPD
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 251d
Cleared Nov 19, 1990
INTEGRATED DIAGNOSTIC SYSTEM W/ADD'L OPTIONS
K902428 · LLZ
GE Medical Systems
Radiology · 172d
Cleared Nov 19, 1990
EMERSON 33-AN NEGATIVE PRESSURE RESPIRATOR ALARM
K902764 · BYT
J. H. Emerson Co.
Anesthesiology · 147d
Cleared Nov 19, 1990
SHAVE PREP TRAY
K902813
Orion Life Systems, Inc.
General Hospital · 145d
Cleared Nov 19, 1990
P.R.G. GUIDEWIRE PLACEMENT SYSTEM
K903036 · KGC
Applied Medical Technologies
Gastroenterology & Urology · 131d
Cleared Nov 19, 1990
FLEXIFLO (R) VERSA-PEG (TM) GASTROSTOMY KIT
K903325 · KNT
Abbott Laboratories
Gastroenterology & Urology · 117d
Cleared Nov 19, 1990
OPHTHASONIC A/P III
K903666 · HPY
Teknar, Inc.
Ophthalmic · 97d
Cleared Nov 19, 1990
PHOTAC-BOND
K904096 · EJK
Espe GmbH (Us)
Dental · 74d
Cleared Nov 19, 1990
SMART SCALE X-RAY PLATFORM
K904138 · FRW
Olympic Medical Corp.
General Hospital · 74d
Cleared Nov 19, 1990
CATH-FINDER(TM) CATHETER TRACKING SYSTEM
K904150 · FOZ
Pharmacia Deltec, Inc.
General Hospital · 73d
Cleared Nov 19, 1990
ADD-A-VIAL
K904855 · LHI
Kendall Mcgaw Laboratories, Inc.
General Hospital · 21d
Cleared Nov 19, 1990
SLIMFLEX, PATIENT EXAMINATION GLOVES
K905033 · LYY
Slim River Latex Sdn. Bhd.
General Hospital · 12d
Cleared Nov 16, 1990
DIOTHERM
K895137 · FLL
Science Regulatory Services Intl.
General Hospital · 457d
Cleared Nov 16, 1990
TRANSCUTANEOUS ELECTRONIC NERVE STIMULATOR
K896825 · GZJ
Infrasonics Corp.
Neurology · 346d
Cleared Nov 16, 1990
SMOOTH STAPLE IMPLANT
K900433 · MDL
Interphase Implants, Inc.
Dental · 290d