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
90385–90408 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 09, 1998
POWDERED GREEN LATEX EXAMINATION GLOVES
K980039 · LYY
Sri Johani Sdn. Bhd.
General Hospital · 35d
Cleared Feb 09, 1998
ABL700 SERIES BLOOD GAS , CO-OXIMETRY, ELECTROLYTE & METABOLITE SYSTEM
K980130 · CHL
Radiometer America, Inc.
Chemistry · 26d
Cleared Feb 09, 1998
POWDER-FREE NITRILE EXAMINATION GLOVES
K980150 · LZA
Masju Sdn. Bhd.
General Hospital · 24d
Cleared Feb 09, 1998
MANAN BILIARY DRAINAGE CATHETER
K980191 · FGE
Medical Device Technologies, Inc.
Gastroenterology & Urology · 20d
Cleared Feb 06, 1998
PRECISION FLOW OSV II
K971799 · JXG
Elekta Implants, SA
Neurology · 267d
Cleared Feb 06, 1998
PEBA ANCHOR/SUTURE COMBINATION
K972326 · MBI
Orthopaedic Biosystems, Ltd.
Orthopedic · 228d
Cleared Feb 06, 1998
HIMEX CENTRIFLOW CENTRIFUGAL PERFUSION PUMP SYSTEM (CFK01)
K972740 · KFM
Himex Production Corp.
Cardiovascular · 199d
Cleared Feb 06, 1998
MEDTRONIC TWIST LOCK ANCHOR (PARTNUMBER 103953/3550TLA)
K972906 · GZB
Medtronic Vascular
Neurology · 184d
Cleared Feb 06, 1998
AMPLAID MK22
K972959 · GWF
Amplifon S.P.A.
Neurology · 179d
Cleared Feb 06, 1998
THROMBOLYTIC BRUSH CATHETER, OVER THE WIRE (OTW)
K973669 · MCW
Micro Therapeutics, Inc.
Cardiovascular · 134d
Cleared Feb 06, 1998
PERIOPERATIVE DATA MANAGEMENT SYSTEM
K973949 · BSZ
Draeger Medical, Inc.
Anesthesiology · 113d
Cleared Feb 06, 1998
DATEX-ENGSTROM NETWORK
K974101 · MSX
Datex-Engstrom, Inc.
Cardiovascular · 99d
Cleared Feb 06, 1998
ACUTE CARDIAC ISCHEMIA TIME-INSENSITIVE PREDICTIVE INSTRUMENT (ACI-TIPI) OPTION
K974199 · LOS
Marquette Medical Systems, Inc.
Cardiovascular · 88d
Cleared Feb 06, 1998
KNITTED WOUND DRESSING-STANDARD, WCL AND RIBBON
K974205 · KMF
Convatec, A Division of E.R. Squibb &...
General & Plastic Surgery · 88d
Cleared Feb 06, 1998
SILICONE TISSUE/INFLATABLE TISSUE EXPANDER
K974209 · LCJ
Specialty Surgical Products, Inc.
General & Plastic Surgery · 88d
Cleared Feb 06, 1998
CLK INT'L. SANITARY LATEX PROBE COVER, CLK ULTRASOUND PROBE COVER
K974301 · ITX
Clk Intl., Inc.
Radiology · 81d
Cleared Feb 06, 1998
NOMOS SLIT COLLIMATOR (BEAK)
K974310 · IYE
Nomos Corp.
Radiology · 81d
Cleared Feb 06, 1998
UNI-ROM TOTAL HIP SYSTEM FEMORAL STEM
K974331 · LPH
Johnson & Johnson Professionals, Inc.
Orthopedic · 80d
Cleared Feb 06, 1998
CORDIS BRITE TIP CATHETER SHEATH INTRODUCER SYSTEM
K974448 · DYB
Cordis Corp.
Cardiovascular · 73d
Cleared Feb 06, 1998
A-2000 EEG MONITOR WITH BIS
K974496 · OLW
Aspect Medical Systems, Inc.
Neurology · 70d
Cleared Feb 06, 1998
EXTERNAL FUNCTIONAL NEUROMUSCULAR STIMULATOR
K974514 · GZI
Neuromotion, Inc.
Neurology · 67d
Cleared Feb 06, 1998
SPYROFLEX FOAM ISLAND WOUND DRESSING, SPYROFLEX FOAM ISLAND WOUND DRESSING,...
K974520 · MGP
Innovative Technologies (Us), Inc.
General & Plastic Surgery · 66d
Cleared Feb 06, 1998
DUFFUSION-WEIGHTED MR IMAGING PACKAGE
K974530 · LNH
Philips Medical Systems (Cleveland),...
Radiology · 66d
Cleared Feb 06, 1998
P.T. MACHINE
K974626 · JFB
Goodman, Goodman & Goodman
Physical Medicine · 57d