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
49849–49872 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 29, 2010
CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000
K101261 · NFK
C.R. Bard, Inc.
Gastroenterology & Urology · 85d
Cleared Jul 29, 2010
ST/AR ST AND ARRHYTHMIA SOFTWARE MODEL: RELEASE K.O
K101521 · MHX
Philips Medical Systems
Cardiovascular · 57d
Cleared Jul 29, 2010
Q-SWITCHED ND:YAG LASER SYSTEM, MODEL GLOBALCURE-SC6
K102050 · GEX
Advanced Technology Laser Co., Ltd.
General & Plastic Surgery · 8d
Cleared Jul 28, 2010
ADVIA 2120/2120I BODY FLUIDS
K090346 · GKZ
Siemens Healthcare Diagnostics
Hematology · 532d
Cleared Jul 28, 2010
AMPHETAMINES II ASSAY
K093664 · DKZ
Roche Diagnostics Corp.
Chemistry · 243d
Cleared Jul 28, 2010
FIREBIRD SPINAL FIXATION SYSTEM
K093926 · NKB
Blackstone Medical, Inc.
Orthopedic · 218d
Cleared Jul 28, 2010
VARIOUS DENTAL IMPLANTS
K100411 · DZE
Grundy Advanced Biomedical Systems, LLC
Dental · 162d
Cleared Jul 28, 2010
DERMA+FLEX QS HIGH VISCOSITY TISSUE ADHESIVE MODEL: QS70404
K101276 · MPN
Chemence Medical Products, Inc.
General & Plastic Surgery · 83d
Cleared Jul 28, 2010
MROPEN
K101295 · LNH
Paramed S.R.L.
Radiology · 79d
Cleared Jul 28, 2010
JOINSOON ELECTRONICS MFG CO., LTD INFRARED EAR THERMOMETER, MODEL TT-001
K101322 · FLL
Joinsoon Electronics Mfg Co, Ltd.
General Hospital · 78d
Cleared Jul 28, 2010
POWERWIRE RADIOFREQUENCY GUIDEWIRE
K101615 · PDU
Baylis Medical Co., Inc.
Cardiovascular · 49d
Cleared Jul 28, 2010
ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM
K101678 · MNH
Spineart
Orthopedic · 43d
Cleared Jul 28, 2010
HYDROFIX VASO SHIELD, MODEL HVS-001-0610
K101826 · OMR
Mimedx Group, Inc.
Cardiovascular · 27d
Cleared Jul 28, 2010
XPERT MRSA/SA BC (BLOOD CULTURE) ASSAY MODEL GXMRSA/SA-BC-10
K101879 · NQX
Cepheid
Microbiology · 22d
Cleared Jul 28, 2010
PEDIATRIC BODY-CARDIAC COIL, MODEL: 5000012601
K101949 · MOS
Shanghai Chenguang Medical...
Radiology · 16d
Cleared Jul 28, 2010
TALYMED
K102002 · FRO
Marine Polymer Technologies
General & Plastic Surgery · 13d
Cleared Jul 27, 2010
MAM COOLER
K093266 · KKO
Mam International AG
Dental · 281d
Cleared Jul 27, 2010
AESCULAP STERILCONTAINER S
K093493 · FRG
Aesculap, Inc.
General Hospital · 259d
Cleared Jul 27, 2010
TRANSBOND IDB PRE-MIX CHEMICAL CARE ADHESIVE
K100536 · DYH
3M Unitek
Dental · 152d
Cleared Jul 27, 2010
POWERED PD-IO INFUSION SYSTEM, EZ-IO HUMERAL HEAD, POWERED PH-IO
K101026 · FMI
Vidacare Corporation
General Hospital · 105d
Cleared Jul 27, 2010
PROWESS PANTHER PROARC, MODEL VERSION 5.0
K101076 · MUJ
Prowess, Inc.
Radiology · 99d
Cleared Jul 27, 2010
RDT3 HANDPIECE HEAD MODEL RDT3
K101172 · EFA
Redent-Nova , Ltd.
Dental · 92d
Cleared Jul 27, 2010
NAVIAID ICVI DEVICE
K101191 · FDF
Smart Medical Systems , Ltd.
Gastroenterology & Urology · 90d
Cleared Jul 27, 2010
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
K101663 · LYZ
Hebei Excellent Plastic Co., Ltd.
General Hospital · 43d