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
79873–79896 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 16, 2001
SAFARI
K010606 · INI
Ranger All Season Corp.
Physical Medicine · 15d
Cleared Mar 16, 2001
ACCUSONIC, MODEL AS-260
K010609 · IMI
Metron Medical Australia, Pty, Ltd.
Physical Medicine · 15d
Cleared Mar 15, 2001
YORAMED, MODEL T-202
K002297 · GZJ
United Yoram Distributors, Inc.
Neurology · 230d
Cleared Mar 15, 2001
WISEBANDS SKIN CLOSURE DEVICE
K002315 · MKY
Wisebands , Ltd.
General & Plastic Surgery · 227d
Cleared Mar 15, 2001
SIGMA DIAGNOSTICS AUTO D-DIMER, MODEL CRS126-A
K003267 · DAP
Sigma Diagnostics, Inc.
Hematology · 148d
Cleared Mar 15, 2001
DIFFMASTER OCTAVIA AUTOMATIC HEMATOLOGY ANALYZER
K003301 · JOY
CellaVision AB
Hematology · 146d
Cleared Mar 15, 2001
MEDICAL DEPOT NEBULIZER, MODEL POWER NEB 2
K003344 · CAF
Medical Depot, Inc.
Anesthesiology · 141d
Cleared Mar 15, 2001
RANDOX GLUCOSE (GOD/PAP)
K003346 · CGA
Randox Laboratories, Ltd.
Chemistry · 141d
Cleared Mar 15, 2001
N PROTEIN STANDARD UY CALIBRATOR
K003501 · JIT
Dade Behring, Inc.
Chemistry · 122d
Cleared Mar 15, 2001
ACON THC ONE STEP MARIJUANA TEST STRIP(URINE)
K003557 · LDJ
ACON Laboratories, Inc.
Toxicology · 118d
Cleared Mar 15, 2001
IFIS-SA INTEGRATED FUCTIONAL IMAGING SYSTEM
K003899 · LNH
Mri Devices Corp.
Radiology · 87d
Cleared Mar 15, 2001
LASEREX INTEGRE, MODEL LP2532
K003955 · GEX
Ellex Medical Pty, Ltd.
General & Plastic Surgery · 84d
Cleared Mar 15, 2001
PANASONIC TELE-HOMECARE SYSTEM
K004050 · MWI
Matsushita Electric Industrial Co., Ltd.
Cardiovascular · 76d
Cleared Mar 15, 2001
ULTRAPAK NEHA
K010070 · MVL
Ultradent Products, Inc.
Dental · 66d
Cleared Mar 15, 2001
EEG REAL PATIENT SPIKE AND EVENT DETECTOR MODULE, MODEL EX-SP-RP (PROPOSED)
K010085 · OMB
Excel Tech. , Ltd.
Neurology · 63d
Cleared Mar 15, 2001
SURSHIELD WINGED INFUSION SET
K010103 · FPA
Terumo Medical Corp.
General Hospital · 62d
Cleared Mar 15, 2001
PLANMED SOPHIE, PLANMED SOPHIE CLASSIC
K010116 · IZH
Planmed OY
Radiology · 58d
Cleared Mar 15, 2001
INION CPS BABY 1.5 BIOABSORBABLE FIXATION SYSTEM
K010351 · JEY
Inion , Ltd.
Dental · 37d
Cleared Mar 15, 2001
EPIDURAL CATHETER WITH CONNECTOR (AND ACCESSORY)
K010425 · KNF
Hdc Corp.
Obstetrics & Gynecology · 30d
Cleared Mar 15, 2001
LORENZ FIDUCAIL SCREW
K010427 · HAW
Walter Lorenz Surgical, Inc.
Neurology · 30d
Cleared Mar 15, 2001
MODIFICATION TO ACTICOAT FOAM DRESSING
K010447 · FRO
Westaim Biomedical, Inc.
General & Plastic Surgery · 30d
Cleared Mar 15, 2001
DATEX-OHMEDA OXYGEN SATURATION MODULE, M-OSAT AND ACCESSOIRES
K010463 · DQA
Datex-Ohmeda, Inc.
Anesthesiology · 27d
Cleared Mar 15, 2001
MODIFICATION TO BINAX NOW STREPTOCOCCUS PNEUMONIAE URINARY ANTIGEN TEST
K010523 · GTZ
Binax, Inc.
Microbiology · 21d
Cleared Mar 15, 2001
OLYMPUS EU-C60 EUS EXERA COMPACT ENDOSCOPIC ULTRASOUND CENTER
K010591 · ODG
Olympus Optical Co., Ltd.
Radiology · 15d