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
75769–75792 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 03, 2002
CARESIDE LDH
K020484 · CFH
Careside, Inc.
Chemistry · 140d
Cleared Jul 03, 2002
POLY-CHEM GLUCOSE
K020852 · CFR
Polymedco, Inc.
Chemistry · 110d
Cleared Jul 03, 2002
LIGHT SABER SPINAL NEEDLE
K021084 · FMF
Minrad, Inc.
Radiology · 90d
Cleared Jul 03, 2002
INTROCAN SAFETY IV CATHETER
K021094 · DYB
B.Braun Medical, Inc.
Cardiovascular · 90d
Cleared Jul 03, 2002
POWDERED LATEX SURGIACAL GLOVES, STEERILE WITH EXPIRATION DATE LABELING CLAIM
K021159 · KGO
Wrp Asia Pacific Sdn. Bhd.
General Hospital · 83d
Cleared Jul 03, 2002
SEEDNET SYSTEM AND SEEDNETGOLD SYSTEM, MODELS GP6T5, GP5T5, GP5T3, HP5T5 & HP5T3
K021261 · GEH
Galil Medical , Ltd.
General & Plastic Surgery · 75d
Cleared Jul 03, 2002
WIENER LAB. CK-NAC UV UNITEST, WIENER LAB. CK-NAC UV AA, WIENER LAB. CK-NAC...
K021332 · CGS
Wiener Laboratories Saic
Chemistry · 68d
Cleared Jul 03, 2002
AART PECTORALIS IMPLANT
K021337 · MIC
Aesthetic and Reconstructive...
General & Plastic Surgery · 68d
Cleared Jul 03, 2002
MAC-LAB/CARDIOLAB EP/COMBOLAB
K021366 · DQK
General Electric Medical Systems...
Cardiovascular · 64d
Cleared Jul 03, 2002
COALESCENT SURGICAL U-CLIP - OR OTHER TBD AND ACCESSORIES
K021407 · FZP
Coalescent Surgical
General & Plastic Surgery · 61d
Cleared Jul 03, 2002
HEARTSTREAM XL DEFIBRILLATOR/MONITOR, MODEL #M4735A
K021453 · MKJ
Philips Medical Systems
Cardiovascular · 58d
Cleared Jul 03, 2002
MODIFICATION TO ACCU-CHEK ACTIVE SYSTEM
K021827 · NBW
Roche Diagnostics Corp.
Chemistry · 29d
Cleared Jul 03, 2002
SCS CLARIS SPINAL SYSTEM,REXTENDED OMNIAXIAL CONNECTOR-,MEDIUM, MODEL CO05,...
K021919 · KWP
Ortho Tec, LLC
Orthopedic · 22d
Cleared Jul 03, 2002
TRELLIS PLUS INFUSION SYSTEM (140CM CATHETER LENGTH 10CM INFUSION LENGTH 20CM...
K021958 · QEY
Bacchus Vascular, Inc.
Cardiovascular · 19d
Cleared Jul 02, 2002
CRANIAL STEREOTACTIC EQUIPMENT
K010065 · IYE
Arplay Medical S.A.
Radiology · 540d
Cleared Jul 02, 2002
MILLAR PRESSURE CONTROL UNIT MODEL PCU-2000
K013205 · DRQ
Millar Instruments, Inc.
Cardiovascular · 280d
Cleared Jul 02, 2002
RE-ENTRANT CHAMBER
K013689 · KPT
Sun Nuclear Corp.
Radiology · 238d
Cleared Jul 02, 2002
SSIR SYSTEM
K014208 · ILY
Russian-American Technology...
Physical Medicine · 193d
Cleared Jul 02, 2002
DINAMAP PROCARE SERIES MONITOR
K014255 · MWI
Ge Medical Systems Information...
Cardiovascular · 188d
Cleared Jul 02, 2002
LYRA SURGICAL LASER SYSTEM AND ACCESSIORIES (ND:YAG CONFIGURATION)
K020021 · GEX
Laserscope
General & Plastic Surgery · 180d
Cleared Jul 02, 2002
INVACARE PLATINUM, MODELS IRC 5LX AND IRC 5LX02
K020386 · CAW
Invacare Corp.
Anesthesiology · 146d
Cleared Jul 02, 2002
RESPERATE
K020399 · HCC
Intercure , Ltd.
Neurology · 146d
Cleared Jul 02, 2002
ACCUFIX TILTING RADIOTRANSLUCENT HEADHOLDER
K021124 · IYE
Wfr/Aquaplast Corp.
Radiology · 85d
Cleared Jul 02, 2002
D/SENSE 1-STEP
K021146 · EJK
Centrix, Inc.
Dental · 84d