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
66649–66672 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 22, 2005
DUOPROSS SYRINGES
K042500 · FMF
Duopross Meditech Corporation
General Hospital · 161d
Cleared Feb 22, 2005
MEDICOMPASS CONNECT
K042768 · DXN
Imetrikus, Inc.
Cardiovascular · 140d
Cleared Feb 22, 2005
LIBERTY SYSTEM
K043074 · DPS
Inovise Medical, Inc.
Cardiovascular · 106d
Cleared Feb 22, 2005
MULTIPLE, MODEL KTJ-50
K043444 · DXQ
Golden Horse Medical Equipment (Wuxi)...
Cardiovascular · 70d
Cleared Feb 22, 2005
COMPATIBILITY ECG TRUNK CABLES
K043572 · DSA
Datex-Ohmeda
Cardiovascular · 57d
Cleared Feb 22, 2005
MODIFICATION TO: 3M LITTMANN ELECTRONIC STETHOSCOPE, MODEL 3000
K050159 · DQD
3M Company
Cardiovascular · 28d
Cleared Feb 22, 2005
MODIFICATION TO BD FACSCANTO SYSTEM WITH BD FACSCANTO CLINICAL SOFTWARE
K050191 · PER
Becton, Dickinson & CO
Hematology · 26d
Cleared Feb 18, 2005
INTERGRO DBM
K031399 · MQV
Interpore Cross Intl.
Orthopedic · 655d
Cleared Feb 18, 2005
STANSION MATRIX
K042600 · MQP
Spineworks, LLC
Orthopedic · 148d
Cleared Feb 18, 2005
WELL LEAD ENDOTRACHEAL TUBE
K042683 · BTR
Well Lead Medical Instruments
Anesthesiology · 142d
Cleared Feb 18, 2005
INFINITY KAPPA XLT
K042904 · MHX
Draeger Medical Systems, Inc.
Cardiovascular · 120d
Cleared Feb 18, 2005
INTERGARD WOVEN CONNECTOR GRAFT, MODEL IGW0030-10C
K042984 · DWF
Intervascular
Cardiovascular · 112d
Cleared Feb 18, 2005
GENIE MAGIC MIX ULTRA HYDROPHILIC IMPRESSION MATERIAL
K043054 · ELW
Sultan Chemists, Inc.
Dental · 105d
Cleared Feb 18, 2005
INION OTPS BIODEGRADABLE MINI PLATING SYSTEM
K043142 · HWC
Inion , Ltd.
Orthopedic · 95d
Cleared Feb 18, 2005
BI-CORTICAL BIO-POST AND WASHER, MODEL AR-1367B
K043145 · HTN
Arthrex, Inc.
Orthopedic · 95d
Cleared Feb 18, 2005
TRACOE PHON ASSIST I - SPEAKING VALVES, REFERENCE MODELS: PHON ASSIST...
K043160 · JOH
Tracoe Medical GmbH
Anesthesiology · 95d
Cleared Feb 18, 2005
BLAKSTONE LAMINOPLASTY FIXATION SYSTEM
K043338 · NQW
Blackstone Medical, Inc.
Orthopedic · 77d
Cleared Feb 18, 2005
4.5MM BONE-LOK FACET SCREW, MODELS TFCD-45-3040S OR N
K043351 · MRW
Triage Medical, Inc.
Orthopedic · 74d
Cleared Feb 18, 2005
INFINITY MODULAR MONITORS WITH VF5 MODIFICATIONS (DELTA/KAPPA/DELTA XL/VISTA...
K043439 · MHX
Draeger Medical Systems, Inc.
Cardiovascular · 66d
Cleared Feb 18, 2005
SMITH & NEPHEW, INC. REVISION KNEE SYSTEM
K043440 · JWH
Smith & Nephew, Inc.
Orthopedic · 66d
Cleared Feb 18, 2005
PD-IO DISPOSABLE INTRAOSSEOUS INFUSION NEEDLE
K043490 · FMI
Vidacare Corporation
General Hospital · 63d
Cleared Feb 18, 2005
DATEX-OHMEDA S/5 PSM MODULE, (CONSISTING OF E-PSM AND E-PSMP MODULES) AND...
K043551 · MHX
Datex-Ohmeda
Cardiovascular · 57d
Cleared Feb 18, 2005
SILVERHAWK PERIPHERAL PLAQUE EXCISION SYSTEM, MODELS 02550,04800, 05200,...
K043553 · MCW
Fox Hollow Technologies
Cardiovascular · 53d
Cleared Feb 18, 2005
SECURELOC
K050023 · DYB
Specialized Health Products, Inc.
Cardiovascular · 44d