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

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176,076 results
77761–77784 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 17, 2001
TEKMEDIC POWDER-FREE WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS)
K013317 · LYY
Tekmedic (M) Sdn Bhd
General Hospital · 74d
Cleared Dec 17, 2001
SUMMIT CEMENTED HIP PROSTHESIS
K013352 · JDI
DePuy Orthopaedics, Inc.
Orthopedic · 69d
Cleared Dec 17, 2001
ACE BIO WIN TIBIAL NAILING SYSTEM
K013430 · HSB
DePuy Orthopaedics, Inc.
Orthopedic · 62d
Cleared Dec 17, 2001
SELF-COUNTERSINKING BONE SCREW
K013534 · HWC
Biomet Orthopedics, Inc.
Orthopedic · 55d
Cleared Dec 17, 2001
OSSEOTITE DENTAL IMPLANTS
K013570 · DZE
Implant Innovations, Inc.
Dental · 52d
Cleared Dec 17, 2001
DRG ORTHOHEX SS BONE SCREW
K013786 · HWC
Doctor'S Research Group, Inc.
Orthopedic · 33d
Cleared Dec 17, 2001
HELICAL COMPRESSION ANCHOR SYSTEM, CANNULATED, VERSION 2
K013903 · HWC
Triad Medical, Inc.
Orthopedic · 21d
Cleared Dec 17, 2001
H/S ELLIPTOSPHERE CATHETER SET, MODEL 61-4005
K013972 · LKF
Ackard Laboratories
Obstetrics & Gynecology · 14d
Cleared Dec 14, 2001
DERMACLEAR UV-B PHOTOTHERAPY SYSTEM
K011197 · FTC
Lumenis
General & Plastic Surgery · 239d
Cleared Dec 14, 2001
AIA-PACK CTNI 2ND-GEN ASSAY
K012820 · MMI
Tosoh Medics, Inc.
Chemistry · 113d
Cleared Dec 14, 2001
ORTHOSONIX ENERGEX
K013094 · NHH
Orthosonix, Inc.
Neurology · 88d
Cleared Dec 14, 2001
ASMOTOM AUTOMATED TREPHINE SYSTEM
K013151 · HRG
Bkg Opthalmics USA, Inc.
Ophthalmic · 85d
Cleared Dec 14, 2001
RENMED CONTAMI-SHIELD BREATHING CIRCUIT SLEEVE, MODEL 9999/01
K013200 · CAH
Rennels Medical Corp.
General Hospital · 80d
Cleared Dec 14, 2001
GORE INTRODUCER SHEATH
K013282 · DBY
W.L. Gore & Associates, Inc.
Immunology · 73d
Cleared Dec 14, 2001
NIPRO HYPODERMIC NEEDLE
K013293 · FMI
Nipro Medical Corp.
General Hospital · 73d
Cleared Dec 14, 2001
CTS-415
K013327 · IYO
Shantou Institute of Ultrasonic...
Radiology · 70d
Cleared Dec 14, 2001
K-SYSTEMS CULTURE BAG SEALER AND CULTURE BAGS TYPE CBS-1 AND CB-01
K013401 · MQG
K-Systems, Kivex Biotec , Ltd.
Obstetrics & Gynecology · 60d
Cleared Dec 14, 2001
ETHANOL
K013538 · DML
Abbott Laboratories
Toxicology · 51d
Cleared Dec 14, 2001
SHOULDER COIL
K013541 · MOS
Usa Instruments, Inc.
Radiology · 51d
Cleared Dec 14, 2001
SANYO CO2 INCUBATORS, MODELS NOS. MCO-17AC, MCO-17AIC, MCO-20AIC,AND MC0-175M
K013703 · MQG
Sanyo North America Corp.
Obstetrics & Gynecology · 36d
Cleared Dec 14, 2001
MODIFICATION TO:APEX MEDICAL IF-4100
K013813 · GXY
Apex Medical Corp.
Neurology · 28d
Cleared Dec 14, 2001
CONVOY ADVANCED DELIVERY SHEATH KIT
K013866 · DBY
Boston Scientific
Immunology · 23d
Cleared Dec 14, 2001
JOSTRA FLOWPROBE FP-32E
K013939 · DPT
Jostra AG
Cardiovascular · 15d
Cleared Dec 13, 2001
STRESS GUARD, MODEL HERDEV1
K004008 · GZJ
Herbo Medex International, Inc.
Neurology · 352d