Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
62497–62520 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 16, 2006
COOL.CLICK 2
K060819 · KZE
Medical House Products Limited
General Hospital · 81d
Cleared Jun 16, 2006
SMARTINFUSER PAINPUMP, MODEL P49220 W/CATHETER SET
K061409 · MEB
Precise Medical Products, Ltd.
General Hospital · 25d
Cleared Jun 15, 2006
ACRO BIOTECH LLC RAPID OPIATES URINE TEST
K053037 · DJG
Acro Biotech, LLC
Toxicology · 231d
Cleared Jun 15, 2006
WELCH ALLYN CONNEX VITAL SOLUTIONS SOFTWARE
K053381 · DQA
Welch Allyn, Inc.
Anesthesiology · 192d
Cleared Jun 15, 2006
RAPIDONE-COCAINE-150 TEST
K053422 · DIO
American Bio Medica Corp.
Toxicology · 189d
Cleared Jun 15, 2006
APEX KNEE SYSTEM
K060192 · JWH
Omni Life Science, Inc.
Orthopedic · 141d
Cleared Jun 15, 2006
CMB ANTIMICROBIAL DRESSING
K060237 · FRO
Silverleaf Medical Products, Inc.
General & Plastic Surgery · 136d
Cleared Jun 15, 2006
VACU LAB PLAIN TUBE, VACU LAB GEL & CLOT ACTIVATOR TUBE, VACU LAB COAGULATION...
K060364 · JKA
Teco Diagnostics
Chemistry · 122d
Cleared Jun 15, 2006
DOLPHIN 2000 DATEX COMPATIBLE OXIMETRY DISPOSABLE AND REUSABLE SENSORS AND...
K060524 · DQA
Dolphin Medical, Inc.
Anesthesiology · 108d
Cleared Jun 15, 2006
MULTIGENT GENTAMICIN
K060709 · LCD
Seradyn, Inc.
Toxicology · 91d
Cleared Jun 15, 2006
OMNILINK. 018 BILIARY STENT SYSTEM
K060817 · FGE
Guidant Endovascular Solutions, Inc.
Gastroenterology & Urology · 80d
Cleared Jun 15, 2006
MILAGRO INTERFERENCE SCREW
K060830 · HWC
Depuy Mitek, A Johnson & Johnson Company
Orthopedic · 80d
Cleared Jun 15, 2006
ACCU-CHEK INSULIN PUMP CONFIGURATION SOFTWARE (STANDARD), MODEL 04625137001
K060876 · LZG
Disetronic Medical Systems AG
General Hospital · 76d
Cleared Jun 15, 2006
CZ-S2000
K060946 · KIF
Parkell, Inc.
Dental · 70d
Cleared Jun 15, 2006
SNAP II EEG MONITOR
K060997 · OLW
Everest Biomedical Instruments Co.
Neurology · 66d
Cleared Jun 15, 2006
VITROS CHEMISTRY PRODUCTS TIBC KIT, MODEL 886 7541
K061464 · JMO
Ortho-Clinical Diagnostics, Inc.
Chemistry · 21d
Cleared Jun 15, 2006
ENSEAL PTC TISSUE SEALING DEVICE
K061526 · GEI
Surgrx, Inc.
General & Plastic Surgery · 13d
Cleared Jun 14, 2006
BLUE POWDER FREE NITRILE EXAMINATION GLOVES
K052583 · LZA
Hartalega Sdn Bhd
General Hospital · 267d
Cleared Jun 14, 2006
DAN MONOPOLAR LAP ACCESSORIES
K052759 · GEI
Dannoritzer Medizintechnik GmbH & Co. KG
General & Plastic Surgery · 257d
Cleared Jun 14, 2006
ENDOTOOL DRUG DOSE CALCULATOR
K053137 · NDC
MD Scientific, LLC
General Hospital · 217d
Cleared Jun 14, 2006
REFLECTION 3-HOLE SHELL WITH ASYMMETRIC POROUS COATING
K060630 · LPH
Smith & Nephew, Inc.
Orthopedic · 97d
Cleared Jun 14, 2006
CARINA HOME
K060705 · CBK
Draeger Medical B.V.
Anesthesiology · 90d
Cleared Jun 14, 2006
DYNATRON ION IONTOPHORESIS ELECTRODE
K060814 · EGJ
Dynatronics Corp.
Physical Medicine · 79d
Cleared Jun 14, 2006
ABBOTT AXSYM TROPONIN-I ADV
K060875 · MMI
Abbott Laboratories
Chemistry · 76d