FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
76969–76992 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 10, 2002
DATEX-OHMEDA S/5 BIS MODULE, M-BIS AND ACCESSORIES
K013389 · OLW
Datex-Ohmeda
Neurology · 90d
Cleared Jan 10, 2002
INTUITIVE SURGICAL ENDOWRIST ENDOSCOPIC INSTRUMENT FAMILY
K013416 · GEI
Intuitive Surgical, Inc.
General & Plastic Surgery · 87d
Cleared Jan 10, 2002
MISONIX IRRIGATION SYSTEM MOEDL BC20P
K013417 · GBX
Misonix, Inc.
General & Plastic Surgery · 87d
Cleared Jan 10, 2002
DYNAPULSE 5200A PATHWAY BLOOD PRESSURE MONITORING SYSTEM
K013478 · DXN
Pulse Metric, Inc.
Cardiovascular · 83d
Cleared Jan 10, 2002
INFINITY EXPLORER
K013515 · DXJ
Siemens Medical Solutions USA, Inc.
Cardiovascular · 80d
Cleared Jan 10, 2002
VENTED VIAL ACCESS DEVICE
K013950 · FPA
Churchill Medical Systems, Inc.
General Hospital · 41d
Cleared Jan 10, 2002
MINIBLASTER
K013969 · KOJ
Deldent , Ltd.
Dental · 38d
Cleared Jan 10, 2002
GE LOGIQ 5
K014097 · IYN
GE Medical Systems
Radiology · 29d
Cleared Jan 10, 2002
MAC 5000 ECG ANALYSIS SYSTEM
K014108 · DQK
General Electric Medical Systems...
Cardiovascular · 28d
Cleared Jan 10, 2002
7MM EXTENDED LENGTH ENDOSCOPE,DISSECTION TIPS, MODELS VH-1111, VH-1114
K014250 · GCJ
Guidant Corp.
General & Plastic Surgery · 15d
Cleared Jan 09, 2002
COAPTITE LARYNGEAL AUGMENTATION SYSTEM 1CC & O.5CC, MODELS 0008021-1, 0008022-1
K013243 · KHJ
Bioform, Inc.
Ear, Nose, Throat · 103d
Cleared Jan 09, 2002
NEXGEN COMPLETE KNEE SOLUTION ROTATNG HINGE KNEE
K013385 · KRO
Zimmer, Inc.
Orthopedic · 89d
Cleared Jan 09, 2002
POINT 4 TRANSLUCENT MODIFIED
K013529 · EBF
Sybron Dental Specialties, Inc.
Dental · 78d
Cleared Jan 09, 2002
EPOCA CODR STEM AND HEAD
K014049 · KWT
Stelkast Company
Orthopedic · 30d
Cleared Jan 08, 2002
SEAL-ON TOPICAL HEMPSTATIC POWDER SPRAY
K010933 · QSY
Alltracel Pharma , Ltd.
General & Plastic Surgery · 286d
Cleared Jan 08, 2002
SURX RADIOFREQUENCY ELECTROSURGICAL GENERATOR SYSTEM AND ACCESSORIES (SURX LP...
K011190 · MUK
Surx, Inc.
Gastroenterology & Urology · 264d
Cleared Jan 08, 2002
RODA (REAL TIME OXYGEN DYNAMICS ANALYSIS) MONITORING SYSTEM
K011238 · LZF
Metracor Technologies, Inc.
General Hospital · 260d
Cleared Jan 08, 2002
SABRE COMPAC
K011842 · GWJ
Sle Limited
Neurology · 210d
Cleared Jan 08, 2002
WAMPOLE HS-CRP ELISA
K011855 · DCN
Carter-Wallace, Inc.
Chemistry · 209d
Cleared Jan 08, 2002
DOLPHIN II FLUID MANAGEMENT SYSTEM, MODEL DOL-2
K011876 · HIG
Circon Video
Obstetrics & Gynecology · 207d
Cleared Jan 08, 2002
BIOCHECK HUMAN CARDIAC TROPONIN-I IMMUNOASSAY TEST KIT
K013062 · MMI
Biocheck, Inc.
Chemistry · 118d
Cleared Jan 08, 2002
PROLITE PULSED LIGHT SYSTEM FOR THE TREATMENT OF PIGMENTED LESIONS AND THE...
K013365 · GEX
Medical Bio Care Sweden AB
General & Plastic Surgery · 90d
Cleared Jan 08, 2002
PROLITE PULSED LIGHT SYSTEM FOR THE REMOVAL OF UNWANTED HAIR
K013366 · GEX
Medical Bio Care Sweden AB
General & Plastic Surgery · 90d
Cleared Jan 08, 2002
DATEX-OHMEDA S/5 WEB VIEWER
K013387 · MSX
Datex-Ohmeda
Cardiovascular · 88d