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
52729–52752 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 23, 2009
CARDIOTECH SPIROMETRY SYSTEM, MODEL GT-105
K090646 · BZG
Chest M.I., Inc.
Anesthesiology · 134d
Cleared Jul 23, 2009
LIFEGUARD BACKTRACK B90 BREATH ALCOHOL TESTER
K090766 · DJZ
Lifeloc Technologies, Inc.
Chemistry · 122d
Cleared Jul 23, 2009
IONOLUX
K090817 · EMA
Voco GmbH
Dental · 120d
Cleared Jul 23, 2009
INSUFLOW CO2IONSHIELD
K090879 · FCX
Lexion Medical, LLC
Gastroenterology & Urology · 114d
Cleared Jul 23, 2009
OMNI 5 TOTAL O2 DELIVERY SYSTEM
K091028 · CAW
Respironics, Inc.
Anesthesiology · 104d
Cleared Jul 23, 2009
ASCENT PORCELAIN PRIMER, MODEL 006-00078, 00600079
K091300 · KLE
CAO Group, Inc.
Dental · 80d
Cleared Jul 23, 2009
NOVAPRO VINYL EXAMINATION GLOVE POWDER FREE (NON-COLORED)
K091421 · LYZ
Novapro Co., Ltd.
General Hospital · 71d
Cleared Jul 23, 2009
VASCU-PICC AND MIDLINE CATHETERS, SINGLE, DOUBLE AND TRIPLE LUMEN
K091586 · LJS
Medcomp
General Hospital · 51d
Cleared Jul 23, 2009
TEMPORARY C&B COMPOSITE
K091894 · EBG
Voco GmbH
Dental · 29d
Cleared Jul 22, 2009
POWDERED VINYL PATIENT EXAMINATION GLOVES
K082647 · LYZ
Tangshan Dar Plastic & Rubber...
General Hospital · 314d
Cleared Jul 22, 2009
ACTICOAT FLEX 7 DRESSING
K083113 · FRO
Smith & Nephew, Inc.
General & Plastic Surgery · 274d
Cleared Jul 22, 2009
ALATECH POWDER FREE LATEX EXAMINATION GLOVE
K083761 · LYY
Alatech Healthcare, LLC
General Hospital · 216d
Cleared Jul 22, 2009
CONQUEST SPINAL SYSTEM
K090320 · NKB
Life Spine
Orthopedic · 163d
Cleared Jul 22, 2009
EP15 SOFTWARE MODULE, EP25 SOFTWARE MODULE
K090406 · EWO
Interacoustics AS
Ear, Nose, Throat · 155d
Cleared Jul 22, 2009
COAXIAL ACCORDION ERCP DEVICE, MODELS C0AC19001, COAC20005, COAC22003
K090485 · LQR
Percutaneous Systems, Incorporated
Gastroenterology & Urology · 147d
Cleared Jul 22, 2009
SPIDER SINGLE PORT SURGICAL DEVICE, SUPPORT ARM ACCESSORY, MODEL 90001,...
K090902 · GCJ
Transenterix, Inc.
General & Plastic Surgery · 112d
Cleared Jul 22, 2009
ADKINS STRUT
K091058 · HRS
Biomet Microfixation, Inc.
Orthopedic · 100d
Cleared Jul 22, 2009
PG471W , PG471/50W, PG474W, PG477W, PG479/32W, PG479/50W, PG479/75W FIAB...
K091163 · GXY
Fiab Spa
Neurology · 91d
Cleared Jul 22, 2009
IMPLANT CENTER 2
K091252 · DZI
Satelec
Dental · 84d
Cleared Jul 22, 2009
MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS, MODEL B1017
K091264 · LTT
Siemens Healthcare Diagnostics
Microbiology · 83d
Cleared Jul 22, 2009
DEUCE POLYPECTOMY SNARE, MODELS 000995, 000996,000997, 000998
K091355 · FDI
Conmed Endoscopic Technologies, Inc.
Gastroenterology & Urology · 75d
Cleared Jul 22, 2009
VINYL POWDER FREE EXAMINATION GLOVE
K091383 · LYZ
Shun Tong Co., Ltd.
General Hospital · 72d
Cleared Jul 22, 2009
GCUC-505
K091388 · EBF
GC America, Inc.
Dental · 72d
Cleared Jul 22, 2009
VINYL POWDER FREE EXAMINATION GLOVE
K091429 · LYZ
Shun DA (Xinghua) Co., Ltd.
General Hospital · 70d