FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
90913–90936 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Feb 06, 1998
DIGENE DML 2000 MICROPLATE LUMINOMETER
K980120 · JJQ
Digene Corp.
Chemistry · 24d
Cleared Feb 06, 1998
MRI CHIBA,SPINAL,BREAST LOCALIZATION,AUTOMATIC CUTTING NEEDLES
K980211 · KNW
Manan Medical Products, Inc.
Gastroenterology & Urology · 16d
Cleared Feb 05, 1998
MAGNETIC RESONANCE DIAGNOSTIC SYSTEM
K972990 · LNH
GE Medical Systems
Radiology · 177d
Cleared Feb 05, 1998
DYRACT AP RESTORATIVE
K973235 · EBF
Dentsply Intl.
Dental · 161d
Cleared Feb 05, 1998
IMEX STETHODOP
K973336 · JAF
Imex Medical Systems, Inc.
Radiology · 154d
Cleared Feb 05, 1998
HEMORRELIEF DEVICE
K973590 · LKX
A.Stein - Regulatory Affairs Consulting
Gastroenterology & Urology · 136d
Cleared Feb 05, 1998
STERILE WATER FOR DEVICE IRRIGATION/ STERILE SALINE FOR DEVICE IRRIGATION
K973734 · JOL
Welcon, Inc.
General Hospital · 128d
Cleared Feb 05, 1998
AIR OXYGE MIXER
K974372 · BZR
Sk Med
Anesthesiology · 77d
Cleared Feb 05, 1998
EASYBLOOD GAS ANALYZER
K974526 · CHL
Medica Corp.
Chemistry · 65d
Cleared Feb 05, 1998
SINGER ACUPUNCTURE NEEDLES
K974616 · MQX
Lorac, Inc.
General Hospital · 56d
Cleared Feb 05, 1998
ACCURUN(TM) 130 BORRELIA BURGDORFERI IGG POSITIVE CONTROL
K974809 · LSR
Boston Biomedica, Inc.
Microbiology · 44d
Cleared Feb 05, 1998
ACCURUN(TM) 132 BORRELIA BURDORFERI IGM POSITIVE CONTROL
K974810 · LSR
Boston Biomedica, Inc.
Microbiology · 44d
Cleared Feb 05, 1998
VACUETTE (MULTI-USE HOLDER)
K974873 · JKA
Greiner Meditech, Inc.
Chemistry · 38d
Cleared Feb 05, 1998
CARESIDE BUN
K980057 · CDQ
Exigent Diagnostics, Inc.
Chemistry · 30d
Cleared Feb 05, 1998
VACUTAINER BRAND PRONTO NEEDLES HOLDER
K980098 · JKA
Becton Dickinson Vacutainer Systems
Chemistry · 24d