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

Filters: Cleared only ×
176,076 results
74233–74256 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 04, 2002
NICORE MODEL NCP-1 EXTERNAL COUNTERPULSATION DEVICE
K023016 · DRN
Nicore Equipment & Leasing, Inc.
Cardiovascular · 85d
Cleared Dec 04, 2002
I-PLANT MODEL 3500 (125IODINE BRACHYTHERAPY SEEDS)-STERILE
K023242 · KXK
Implant Sciences Corp.
Radiology · 65d
Cleared Dec 04, 2002
PEDIATRIC ARTERIAL CANNULA
K023251 · DWF
Polystan A/S
Cardiovascular · 65d
Cleared Dec 04, 2002
GIZMO
K023574 · IOR
Freedom Designs, Inc.
Physical Medicine · 41d
Cleared Dec 04, 2002
PVS 1600 SYNCHRO 0.010 NEURO GUIDE WIRE
K023700 · DQX
Precision Vascular Systems, Inc.
Cardiovascular · 30d
Cleared Dec 04, 2002
QUICKSET MIMIX BONE VOID FILLER
K023718 · GXP
Walter Lorenz Surgical, Inc.
Neurology · 29d
Cleared Dec 04, 2002
MODIFICATION TO BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR...
K023810 · JEY
Bioplate, Inc.
Dental · 19d
Cleared Dec 04, 2002
M3046A (M2/M3/M4) COMPACT PORTABLE PATIENT MONITOR AND MP60 & MP70 INTELLIVUE...
K023871 · MHX
Philips Medical Systems
Cardiovascular · 14d
Cleared Dec 03, 2002
NEWCOR
K020440 · DQK
Siemens Medical Systems, Inc.
Cardiovascular · 295d
Cleared Dec 03, 2002
DAUM-LECTRIC MRI DRILLING MACHINE
K021098 · ERL
Mri Devices Daum GmbH
Ear, Nose, Throat · 243d
Cleared Dec 03, 2002
ORION DIAGNOSTICA ULTRASENSITIVE CRP KIT, MODEL 68025, & ORION DIAGNOSTICA...
K022176 · DCK
Orion Diagnostica, Div. Orion Corp.
Immunology · 153d
Cleared Dec 03, 2002
IMTEC SENDAX MDI ORTHO6 AND ORTHO8
K023067 · DZE
Imtec Corp.
Dental · 78d
Cleared Dec 03, 2002
STERIPACK STERILE DISPOSABLE SYRINGE & STERILE DISPOSABLE INSULIN SYRINGE
K023108 · FMF
Atlantic Products, Inc.
General Hospital · 76d
Cleared Dec 03, 2002
T-WAVE ALTERMANS (TWA) ALGORITHM OPTION
K023380 · DQK
General Electric Medical Systems...
Cardiovascular · 56d
Cleared Dec 03, 2002
MODIFICATION TO ENVOY PATIENT MONITOR
K023798 · DSI
Mennen Medical , Ltd.
Cardiovascular · 19d
Cleared Dec 02, 2002
ROLOR POWERED MUSCLE STIMULATOR, MODEL GP-8016M
K020130 · IPF
Rolor Electronics Corp.
Physical Medicine · 321d
Cleared Dec 02, 2002
EXEL VACULET BLOOD COLLECTION SET
K020533 · FPA
Exelint Intl. Co.
General Hospital · 286d
Cleared Dec 02, 2002
MOTEX LATEX EXAMINATION GLOVES, POWDER-FREE
K020837 · LYY
Shanghai Motex Healthcare Co., Ltd.
General Hospital · 263d
Cleared Dec 02, 2002
SANIDAD TENS-DUO MODE GP8016N
K021430 · GZJ
Rolor Electronics Corp.
Neurology · 213d
Cleared Dec 02, 2002
V.A.C. INSTILLAMAT (VACUUM ASSISTED CLOSURE INSTILLAMAT
K021501 · OMP
Kinetic Concepts, Inc.
General & Plastic Surgery · 207d
Cleared Dec 02, 2002
WRIST IMPLANT
K021859 · JWJ
Avanta Orthopaedics, Inc.
Orthopedic · 179d
Cleared Dec 02, 2002
HOME CARE JELLY
K022494 · GYB
Roc Chinese-European Industrial...
Neurology · 126d
Cleared Dec 02, 2002
J.P. 3-WHEELED SCOOTER, ES-350 CITYBUG II/ RABBIT
K022518 · INI
Roc Chinese-European Industrial...
Physical Medicine · 125d
Cleared Dec 02, 2002
SOLERA MAGNUM THROMBECTOMY CATHETER, 55 CM, MODEL BAC SMG 007 055 & SOLERA...
K022640 · MCW
Bacchus Vascular, Inc.
Cardiovascular · 116d