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
51385–51408 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 08, 2010
MICRO-STICK SET
K091954 · DYB
Medcomp
Cardiovascular · 191d
Cleared Jan 08, 2010
OC-SENSOR DIANA IFOB TEST
K092330 · OOX
Polymedco Cancer Diagnostics, LLC
Hematology · 157d
Cleared Jan 08, 2010
FINGERTIP PULSE OXIMETER, MODEL MD300CA ND300CA
K092652 · DQA
Beijing Choice Electronic Technololgy...
Anesthesiology · 133d
Cleared Jan 08, 2010
DIMELA OBSTERICAL FORCEPS, MODEL 72.1 XX XX
K092827 · HDA
Dimeda Instrumente GmbH
Obstetrics & Gynecology · 116d
Cleared Jan 08, 2010
HALO ABLATION CATHETER, MODEL 90-9100
K093008 · GEI
Barrx Medical, Incorporated
General & Plastic Surgery · 102d
Cleared Jan 08, 2010
BLOOD PRESSURE MONITOR, MODEL MD200A
K093013 · DXN
Beijing Choice Electronic Technololgy...
Cardiovascular · 101d
Cleared Jan 08, 2010
PCR ELEVA 1.2
K093355 · LLZ
Philips Medical Systems, Inc.
Radiology · 73d
Cleared Jan 08, 2010
CIAGLIA BLUE DOLPHIN BALLOON PERCUTANEOUS TRACHEOSTOMY INTRODUCER, MODEL:...
K093469 · JOH
Cook, Inc.
Anesthesiology · 63d
Cleared Jan 08, 2010
HARDYDISK AST TELAVANCIN,30UG
K093807 · JTN
Hardy Diagnostics
Microbiology · 28d
Cleared Jan 08, 2010
XELERIS 3 PROCESSING AND REVIEW WORKSTATION
K093982 · LLZ
Ge Medical Systems F.I. Haifa
Radiology · 15d
Cleared Jan 07, 2010
MENDASIL TWG GEL ANTIMICROBIAL SKIN AND WOUND GEL
K090345 · FRO
Conseal International, Inc.
General & Plastic Surgery · 331d
Cleared Jan 07, 2010
CARDIO-WRAP
K090637 · DXZ
Mast Biosurgery USA, Inc.
Cardiovascular · 303d
Cleared Jan 07, 2010
CHAMPIONS IMPLANTS GMBH MIMI 1-PIECE PRECISION IMPLANT, MODEL 1000 UP TO 6000
K091182 · DZE
Champions Implants GmbH
Dental · 259d
Cleared Jan 07, 2010
MOUNTAINEER LAMINOPLASTY SYSTEM
K091994 · NQW
Depuy Spine, Inc.
Orthopedic · 189d
Cleared Jan 07, 2010
SERIM D-CIDE GTA 1.5% TEST STRIP, MODEL PART NUMBER 5171
K092346 · JOJ
Serim Research Corp.
General Hospital · 156d
Cleared Jan 07, 2010
DIGITAL THERMOMETER (WITH DISPOSABLE THERMOMETER COVER), DT SERIES
K092447 · FLL
Hangzhou Hua'An Medical & Health...
General Hospital · 150d
Cleared Jan 07, 2010
POGS, MODEL 65/130
K092636 · CAW
On Site Gas Systems, Inc.
Anesthesiology · 133d
Cleared Jan 07, 2010
INF 4160 PLUS, MODEL D-FJ31F
K092780 · LIH
Fuji Dynamics Limited
Neurology · 119d
Cleared Jan 07, 2010
ENDOMAX CORDLESS ENDODONTIC HANDPIECE
K092833 · EKX
Dentamerica
Dental · 114d
Cleared Jan 07, 2010
EXACTECH EQUINOXE PLATFORM FRACTURE STEM AND REVISION PLATFORM FRACTURE STEM
K092900 · PHX
Exactech, Inc.
Orthopedic · 108d
Cleared Jan 07, 2010
MEDLINE CURAD WOUND DRESSINGS
K093349 · FRO
Medline Industries, Inc.
General & Plastic Surgery · 72d
Cleared Jan 07, 2010
VARI-LASE ENDOVENOUS LASER CONSOLE
K093502 · GEX
Vascular Solutions, Inc.
General & Plastic Surgery · 56d
Cleared Jan 07, 2010
MINI RAIL EXTERNAL FIXATOR SYSTEM
K093550 · KTT
Small Bone Innovations, Inc.
Orthopedic · 51d
Cleared Jan 07, 2010
VIDAR DENTAL FILM DIGITIZER
K093809 · LMA
Vidar Systems Corp.
Radiology · 29d