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
66625–66648 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 25, 2005
VORTEX EZ VASCULAR ACCESS PORT
K050176 · LJT
Rita Medical Systems, Inc.
General Hospital · 30d
Cleared Feb 25, 2005
5 SEC DIGITAL CLINICAL THERMOMETER, MODELS ST8630X, ST8640X, ST8730X,...
K050303 · FLL
Mesure Technology Co., Ltd.
General Hospital · 17d
Cleared Feb 25, 2005
THERMAL CAUTERY PROBE
K050308 · HQR
Starion Instruments
Ophthalmic · 17d
Cleared Feb 25, 2005
SET GRI-FILL 3.0-1 WAY, 2 WAYS, MULTIPLE
K050339 · LHI
Laboratorios Grifols, S.A.
General Hospital · 14d
Cleared Feb 25, 2005
MODIFICATION TO CRYOCARE CS SURGICAL SYSTEM
K050347 · GEH
Endocare, Inc.
Radiology · 14d
Cleared Feb 24, 2005
BIOFLEX LD-175 AND LD-1200 TREATMENT HEADS
K041885 · ILY
Meditech International, Inc.
Physical Medicine · 227d
Cleared Feb 24, 2005
KODAK ORTHODONTIC IMAGING AND OMS IMAGING 8.0
K043104 · EHD
Practiceworks, Inc.
Radiology · 107d
Cleared Feb 24, 2005
ELLIPSE LIGHT SPT
K043255 · GEX
Danish Dermatologic Development A/S
General & Plastic Surgery · 92d
Cleared Feb 24, 2005
EPIPHYSIS SCREW
K043410 · HWC
I.T.S. Implantat-Technologie-Systeme...
Orthopedic · 76d
Cleared Feb 24, 2005
DERMILLUME, MODEL PRO1000
K043575 · GEX
Care Electronics, Inc.
General & Plastic Surgery · 59d
Cleared Feb 24, 2005
SECTRA IDS5 WORKSTATION
K050196 · LLZ
Sectra-Imtec AB
Radiology · 28d
Cleared Feb 24, 2005
VIVAWAVE MICROWAVE ABLATION SYSTEM, COAXIAL INTRODUCER
K050223 · GEI
Vivant Medical, Inc.
General & Plastic Surgery · 24d
Cleared Feb 24, 2005
HRK-123 KNEE ARRAY COIL
K050299 · MOS
Mri Devices Corporation
Radiology · 17d
Cleared Feb 24, 2005
BIS SRS (SEMI-RESUABLE SENSOR)
K050313 · GWY
Aspect Medical Systems, Inc.
Neurology · 15d
Cleared Feb 24, 2005
BURANE XL
K050317 · GEX
Wavelight Laser Technologie AG
General & Plastic Surgery · 15d
Cleared Feb 23, 2005
WELLNESS/JOLIVETE
K040905 · IRP
Tohkai Precision Ind. , Ltd.
Physical Medicine · 322d
Cleared Feb 23, 2005
SILIMED PECTORAL IMPLANT
K042054 · MIB
Silimed, Inc.
General & Plastic Surgery · 208d
Cleared Feb 23, 2005
DUREX PLAY WARMER LUBRICANT
K042563 · KMJ
Ssl Americas, Inc.
General Hospital · 155d
Cleared Feb 23, 2005
MEDICON 2.4 MANDIBULAR RECONSTRUCTION PLATING SYSTEM
K043297 · JEY
Medicon EG
Dental · 86d
Cleared Feb 23, 2005
QUADRANT RETRACTOR SYSTEM
K043602 · GAD
Medtronic Sofamor Danek
General & Plastic Surgery · 56d
Cleared Feb 23, 2005
XARIO DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA-660A
K050380 · IYN
Toshiba America Medical Systems, In.C
Radiology · 8d
Cleared Feb 23, 2005
PRIME & BOND NT DUAL CURE NANO-TECHNOLOGY UNIVERSAL DENTAL ADHESIVE SYSTEM
K050386 · KLE
Dentsply International
Dental · 8d
Cleared Feb 22, 2005
FERRIS POLYMEM STERILE BREAST PAD
K031660 · NTX
Ferris Mfg. Corp.
General Hospital · 636d
Cleared Feb 22, 2005
PSD-60/ENDOPLASMA
K042274 · GEI
Olympus Shirakawa Co., Ltd.
General & Plastic Surgery · 183d