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
78769–78792 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 09, 2001
GUIDEWIRE INTRODUCER SAFETY NEEDLE
K011085 · DYB
Medamicus, Inc.
Cardiovascular · 90d
Cleared Jul 09, 2001
CANDELA SPTL-1E PULSED DYE LASER
K011092 · GEX
Candela Corp.
General & Plastic Surgery · 90d
Cleared Jul 09, 2001
MPS ACACIA MEDFLO INFUSION (LI) AND MPS ACACIA MEDFLO INFUSION (LI) KEEP VEIN...
K011117 · MEB
Mps Acacia
General Hospital · 88d
Cleared Jul 09, 2001
COULTER LH 750 HEMATOLOGY ANALYZER, MODEL 6605632
K011342 · GKZ
Beckman Coulter, Inc.
Hematology · 68d
Cleared Jul 09, 2001
JAS CALCIUM (ARSENAZO) REAGENT
K011441 · CJY
Jas Diagnostics, Inc.
Chemistry · 60d
Cleared Jul 09, 2001
DERMASAFE CHEMO PLUS POWDER FREE NEOPRENE EXAMINATION GLOVE (TESTED FOR USE...
K011482 · LZA
Wrp Asia Pacific Sdn. Bhd.
General Hospital · 56d
Cleared Jul 09, 2001
EASY CONTROL MICRO INSERTER, MODEL ON385
K011498 · NCE
Ophtec USA, Inc.
Ophthalmic · 55d
Cleared Jul 09, 2001
MMODIFICATION TO LAMINARIA
K011512 · HDY
A & A Medical, Inc.
Obstetrics & Gynecology · 54d
Cleared Jul 09, 2001
QUANTA LITE H-TTG (HUMAN TISSUE TRANSGLUTAMINASE) IGA ELISA
K011566 · MVM
Inova Diagnostics, Inc.
Immunology · 49d
Cleared Jul 09, 2001
QUANTA LITE H-TTG (HUMAN TISSUE TRANSGLUTAMINASE) IGG ELISA
K011570 · MVM
Inova Diagnostics, Inc.
Immunology · 49d
Cleared Jul 09, 2001
VALIDATION OF THE BREATHID SYSTEM, FOR THE DETECTION OF HELICBACTOR PYLORI
K011668 · MSQ
Oridion Medical 1987 , Ltd.
Microbiology · 53d
Cleared Jul 09, 2001
BW ACUPUNCTURE NEEDLES
K011669 · MQX
H F Intl. Co.
General Hospital · 40d
Cleared Jul 09, 2001
BRIGHTWAY BRAND POWDER FREE LATEX EXAMINATION GLOVES, BLUE NON-STERILE,...
K011728 · LYY
Brightway Holdings Sdn. Bhd.
General Hospital · 35d
Cleared Jul 09, 2001
CAPIOX ARTERIAL FILTER WITH X-COATING, PRODUCT CODE CX*AFO2X
K011804 · DTM
Terumo Cardiovascular Systems Corp.
Cardiovascular · 28d
Cleared Jul 09, 2001
TRILLIUM MYOTHERM XP CARDIOPLEGIA DELIVERY SYSTEM, MODELS 41, 41-B
K011864 · DTN
Medtronic Vascular
Cardiovascular · 25d
Cleared Jul 09, 2001
POWDER-FREE MULTI-PLY LATEX EXAMINATION GLOVES, POLYMER COATED ON OUTSIDE AND...
K011895 · LYY
Pwa Industries Sdn. Bhd.
General Hospital · 21d
Cleared Jul 06, 2001
AMIGO WHEELCHAIR
K010503 · INI
Amigo Mobility Intl., Inc.
Physical Medicine · 135d
Cleared Jul 06, 2001
GLOBAL FX POROUS-COATED HUMERAL STEM
K011099 · MBF
DePuy Orthopaedics, Inc.
Orthopedic · 86d
Cleared Jul 06, 2001
CHATTANOOGA DRY HEAT WHIRLPOOL, MODEL 2000
K011243 · LSB
Chattanooga Group, Inc.
Physical Medicine · 74d
Cleared Jul 06, 2001
PRECISION TUNA OFFICE SYSTEM WITH NO RECTAL TEMPERATURE MONITORING TAPE
K011787 · KNS
Vidamed, Inc.
Gastroenterology & Urology · 28d
Cleared Jul 05, 2001
TITANIUM ABUTMENT HEADS FOR IMZ IMPLANTS
K003818 · DZE
Titan Implants
Dental · 206d
Cleared Jul 05, 2001
BAYER DIAGNOSTICS ADVIA CENTAUR RUBELLA IGM ASSAY
K010668 · LFX
Bayer Corp.
Microbiology · 121d
Cleared Jul 05, 2001
AUTO-DRIVE LAG SCREW SYSTEM
K010964 · HWC
Osteomed Corp.
Orthopedic · 97d
Cleared Jul 05, 2001
PREMIUM
K011130 · ELM
Heraeus Kulzer, Inc.
Dental · 83d