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
78241–78264 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 10, 2001
ASIA-MED ACUPUNCTURE NEEDLES, (STANDARD, SPECIAL, COMPACT, APEX)
K011808 · MQX
Asia-Med GmbH and CO KG
General Hospital · 29d
Cleared Jul 10, 2001
BIS ENGINE
K011834 · OLW
Aspect Medical Systems, Inc.
Neurology · 28d
Cleared Jul 10, 2001
SYNTHETIC POWDER FREE (YELLOW) VINYL PATIENT EXAMINATION GLOVES
K011882 · LYZ
Shijiazhuang Eversharp Plastic...
General Hospital · 22d
Cleared Jul 10, 2001
POWDERED BLUE NITRILE EXAMINATION GLOVES
K011924 · LZA
Seltom Pacific Sdn. Bhd.
General Hospital · 20d
Cleared Jul 10, 2001
MODULAR VALVE HANDLES FOR ADAPTABLE TUBES, MODEL 1298-XX-XX, 1295-XX-XX
K011997 · GCJ
Pajunk GmbH
General & Plastic Surgery · 13d
Cleared Jul 09, 2001
S45 (OCUFILCON A) SPHERICAL, ASPHERICAL, TORIC AND MULTIFOCAL SOFT CONTACT...
K001962 · LPL
Bescon Co., Ltd.
Ophthalmic · 377d
Cleared Jul 09, 2001
S38 (POLYMACON) SPHERICAL, ASPHERICAL, TORIC AND MULTIFOCAL SOFT CONTACT LENS...
K002099 · LPL
Bescon Co., Ltd.
Ophthalmic · 363d
Cleared Jul 09, 2001
GASTRIC SUCTION AND DRAINAGE CATHETER
K002838 · KNT
Bioenterics Corp.
Gastroenterology & Urology · 300d
Cleared Jul 09, 2001
CORTEZ NEEDLE FREE IV CONNECTOR, MODEL MMD-001
K003254 · FPA
Mission Medicl Devices
General Hospital · 265d
Cleared Jul 09, 2001
SPINE WORKS COLLAR
K003662 · HAX
Spine Works
Neurology · 223d
Cleared Jul 09, 2001
US SENSOR #CG-930P
K003876 · HEL
Card Guard Scientific Survival , Ltd.
Obstetrics & Gynecology · 206d
Cleared Jul 09, 2001
BRAIDED GUIDING INTRODUCER
K004026 · DYB
Thomas Medical Products, Inc.
Cardiovascular · 194d
Cleared Jul 09, 2001
TEMPTELLER INFRARED EAR THERMOMETER, MODEL CT-30/ CT-30DX
K010235 · FLL
Oriental System Technology, Inc.
General Hospital · 165d
Cleared Jul 09, 2001
ACON COC ONE STEP COCAINE TEST STRIP, ACON COC ONE STEP COCAINE TEST DEVICE
K010841 · DIO
ACON Laboratories, Inc.
Toxicology · 110d
Cleared Jul 09, 2001
TGL FLEX REAGENT CARTRIDGE
K010871 · CDT
Dade Behring, Inc.
Chemistry · 108d
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