FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
76465–76488 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Jan 08, 2002
LIFEGUARD NASAL CPAP MASK AND ACCESSORIES
K013421 · BZD
Lifeguard Medical Products, Inc.
Anesthesiology · 84d
Cleared Jan 08, 2002
CHLORINATED POWDER FREE LATEX MEDICAL EXAMINATION GLOVES WITH ALOE VERA
K013589 · LYY
Supermax Glove Manufacturing Sdn Bhd
General Hospital · 70d
Cleared Jan 08, 2002
EXTREMITY COIL
K013592 · MOS
Usa Instruments, Inc.
Radiology · 70d
Cleared Jan 08, 2002
VIABAHN ENDOPROSTHESIS
K013648 · JCT
W.L. Gore & Associates, Inc.
General & Plastic Surgery · 64d
Cleared Jan 08, 2002
L-25 ABSORBABLE SURIGCAL SUTURE
K013671 · GAM
United States Surgical, A Division of...
General & Plastic Surgery · 63d
Cleared Jan 08, 2002
MICROLINE INC. REUSABLE LAPAROSCOPIC CLIP APPLIER WITH IMPLANTABLE TITANIUM...
K013695 · GCJ
Microline Pentax, Inc.
General & Plastic Surgery · 62d
Cleared Jan 08, 2002
GYNEMESH PROLENE SOFT (POLYPROPYLENE) NONABSORBABLE SYNTHETIC SURGICAL MESH...
K013718 · OTO
Gynecare, A Div. of Ethicon, Inc.
Obstetrics & Gynecology · 61d
Cleared Jan 08, 2002
BICART
K013724 · KPO
Gambro Renal Products
Gastroenterology & Urology · 60d
Cleared Jan 08, 2002
ROCHE ACETAMINOPHEN
K013757 · LDP
Roche Diagnostics Corp.
Toxicology · 56d