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
79537–79560 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 24, 2001
VIDAS TOTAL PROSTATE SPECIFIC ANTIGEN (TPSA), MODEL 30 428
K010550 · LTJ
bioMerieux, Inc.
Immunology · 57d
Cleared Apr 24, 2001
EUROSPITAL EU-TTG IGA UMANA
K010625 · MVM
Scimedx Corp.
Immunology · 53d
Cleared Apr 24, 2001
POWDER FREE VINYL PATIENT EXAMINATION GLOVES
K010627 · LYZ
Shijiazhuang Junfei Plastic Products...
General Hospital · 53d
Cleared Apr 24, 2001
ACUMATCH M-SERIES EXTRA-SMALL METAPHYSEAL SEGMENTS
K011081 · LPH
Exactech, Inc.
Orthopedic · 14d
Cleared Apr 24, 2001
PASCO MIC AND MIC/ID PANELS INCLUSION OF ESBL CONFIRMATORY TEST
K011116 · LTT
Pasco Laboratories, Inc.
Microbiology · 62d
Cleared Apr 23, 2001
SYNTHES SYNMESH SPACER SYSTEM
K003275 · MQP
Synthes (Usa)
Orthopedic · 186d
Cleared Apr 23, 2001
SHIELDING NEEDLE HOLDER
K003381 · FMI
U.S. Safety Syringes Co., Inc.
General Hospital · 174d
Cleared Apr 23, 2001
PASCO MIC AND MIC/ID PANELS
K010508 · LTT
Pasco Laboratories, Inc.
Microbiology · 61d
Cleared Apr 23, 2001
POWDER FREE (YELLOW) VINYL PATIENT EXAMINATION GLOVES
K010626 · LYZ
Shijiazhuang Junfei Plastic Products...
General Hospital · 52d
Cleared Apr 23, 2001
POWDERED SYNTHETIC VINYL PATIENT EXAMINATION GLOVES
K010628 · LYZ
Shijiazhuang Junfei Plastic Products...
General Hospital · 52d
Cleared Apr 23, 2001
MENTOR STERILE SALINE MAMMARY VOLUME SIZERS
K010709 · MRD
Mentor Corp.
General & Plastic Surgery · 45d
Cleared Apr 23, 2001
TAKE ONE BITE MODIFIED
K010994 · ELW
Kerr Corp.
Dental · 20d
Cleared Apr 20, 2001
ORIGEN BLADDER HOLDER
K003145 · DWC
Origen Biomedical, Inc.
Cardiovascular · 192d
Cleared Apr 20, 2001
SOFTLASE - SURGICAL DIODE LASER SYSTEM
K003440 · GEX
Zap Lasers, Inc.
General & Plastic Surgery · 165d
Cleared Apr 20, 2001
RAPID DRUGS OF ABUSE SINGLE AND MULTIPLE TEST PANELS
K003809 · DKZ
Rapid Diagnostics, Inc.
Toxicology · 133d
Cleared Apr 20, 2001
MODIFICATION TO CAVERMAP SURGICAL AID
K010213 · ETN
Uromed Corp.
Ear, Nose, Throat · 87d
Cleared Apr 20, 2001
CAVITY VARNISH
K010255 · LBH
Rite-Dent Manufacturing Corp.
Dental · 81d
Cleared Apr 20, 2001
DIMENSION CTNI FLEX REAGENT CARTRIDGE
K010313 · MMI
Dade Behring, Inc.
Chemistry · 77d
Cleared Apr 20, 2001
DIMENSION CTNI CALIBRATOR
K010314 · JIT
Dade Behring, Inc.
Chemistry · 77d
Cleared Apr 20, 2001
MEDTRONIC PS MEDICAL MURPHYSCOPE, MODELS 2125-032, 2125033,2125-042,...
K010341 · GWG
Medtronic PS Medical
Neurology · 74d
Cleared Apr 20, 2001
SONOTOME ULTRASONIC ASPIRATOR TIPS
K010637 · LFL
Synergetics, Inc.
General & Plastic Surgery · 46d
Cleared Apr 20, 2001
SIMPLICITY SOFT QD EASY INFUSION SET
K010788 · FPA
Sterling Medivations, Inc.
General Hospital · 36d
Cleared Apr 20, 2001
SYNPLUG
K010840 · LZN
Isotis NV
Orthopedic · 30d
Cleared Apr 20, 2001
NUMED HIGH PRESSURE PTA CATHETERS
K010880 · DQY
NuMED, Inc.
Cardiovascular · 28d