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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
47905–47928 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 24, 2011
NAVITRACK SYSTEM - OS KNEE UNIVERSAL, CAS SAME INCISION TIBIA REFERENCE
K110054 · OLO
Zimmer Cas
Orthopedic · 76d
Cleared Mar 24, 2011
CLEARCANVAS RIS / PACS
K110332 · LLZ
Clearcanvas, Inc.
Radiology · 49d
Cleared Mar 24, 2011
ABL835 FLEX ANALYZER WITH PLEURAL PH
K110416 · CHL
Radiometer Medical Aps
Chemistry · 38d
Cleared Mar 24, 2011
ARCOMXL ACTIVE ARTICULATION
K110555 · LPH
Biomet Manufacturing Corp
Orthopedic · 24d
Cleared Mar 23, 2011
QUANTA FLASH H-TTG IGG
K101644 · MVM
Inova Diagnostics, Inc.
Immunology · 286d
Cleared Mar 23, 2011
CHEM VELOCITY AUTOMATED URINE CHEMISTRY SYSTEM, STRIPS AND CALCHEK KIT
K101852 · KQO
Iris International Inc., A Division...
Chemistry · 265d
Cleared Mar 23, 2011
VENTRIO ST HERNIA PATCH
K101920 · FTL
C.R. Bard, Inc.
General & Plastic Surgery · 257d
Cleared Mar 23, 2011
VENTRALEX ST HERNIA PATCH
K101928 · FTL
C.R. Bard, Inc.
General & Plastic Surgery · 257d
Cleared Mar 23, 2011
ANTHOGYR IMPLANTEO IMPLANTOLOGY AND DENTAL SURGICAL MOTOR UNIT
K102241 · EBW
Anthogyr Sas
Dental · 226d
Cleared Mar 23, 2011
FORZA SPACER SYSTEM
K103111 · MAX
Orthofix, Inc.
Orthopedic · 153d
Cleared Mar 23, 2011
CELSTAT
K103245 · QSY
Baxter Healthcare Corp
General & Plastic Surgery · 141d
Cleared Mar 23, 2011
NON-STERILE, POWDER-FREE, BLUE LATEX EXAMINATION GLOVES, WITHOUT BUBBLE GUM...
K103650 · LYY
Oon Corp. Resources
General Hospital · 99d
Cleared Mar 23, 2011
RUBBERCARE POWDER FREE NITRILE EXAMINATION GLOVE
K103661 · LZA
Rubbercare Protection Products Sdn Bhd
General Hospital · 97d
Cleared Mar 23, 2011
LANX LATERAL
K103666 · MAX
Lanx, Inc.
Orthopedic · 98d
Cleared Mar 23, 2011
PIONEER SPINAL PROCESS FUSION PLATE
K110367 · KWP
Pioneer Surgical Technology, Inc.
Orthopedic · 43d
Cleared Mar 23, 2011
SIMMETRY SACROILIAC JOINT FUSION SYSTEM
K110512 · OUR
Zyga Technology, Inc.
Orthopedic · 28d
Cleared Mar 23, 2011
VALOR(R) ANKLE FUSION NAIL SYSTEM SCREW
K110552 · HSB
Wrightmedicaltechnologyinc
Orthopedic · 23d
Cleared Mar 22, 2011
JTS EXTENDEABLE IMPLANT
K092138 · KRO
Stanmore Implants Worldwide , Ltd.
Orthopedic · 615d
Cleared Mar 22, 2011
ELIBRA UNI SOFT-TISSUE FORCE SENSOR, MODEL 61-XXXX(5 MODELS, DIFFERENT SIZES
K093046 · ONN
Synvasive Technology, Inc.
Orthopedic · 538d
Cleared Mar 22, 2011
THE POWER WAND SAFETY INTRODUCER WITH AN EXTENDED DWELL CATHETER
K101422 · DYB
Access Scientific, Inc.
Cardiovascular · 306d
Cleared Mar 22, 2011
CONFIDENT SURGERY SUITE 300, MODEL CSS300
K101887 · IZD
Surgiceye GmbH
Radiology · 259d
Cleared Mar 22, 2011
ROTATING GAMMA SYSTEM INFINI (INFINI)
K102533 · IWB
Masep Medical Science &...
Radiology · 200d
Cleared Mar 22, 2011
APOLONIA LASER IMPLANT SYSTEM
K102635 · DZE
Csm Implant Co., Ltd.
Dental · 190d
Cleared Mar 22, 2011
IDEAL IQ SOFTWARE OPTION
K103411 · LNH
GE Medical Systems
Radiology · 120d