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
82393–82416 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 01, 2000
HARDYDISK CEFONICID, 30 MCG
K001490 · JTN
Hardy Diagnostics
Microbiology · 20d
Cleared Jun 01, 2000
STERRAD BI TEST PACK
K993775 · FRC
Advanced Sterilization Products
General Hospital · 206d
Cleared Jun 01, 2000
LASER SYSTEM MEDIOSTAR H (WITH AND WITHOUT SKIN COOLING SYSTEM)
K994116 · GEX
Aesculap-Meditec North America
General & Plastic Surgery · 178d
Cleared May 31, 2000
FAST-CATH 18F HEMOSTASIS INTRODUCER, MODEL 406XXX
K001367 · DYB
St. Jude Medical, Inc.
Cardiovascular · 30d
Cleared May 31, 2000
RELIANCE FAMILY OF WASHER-DISINFECTORS
K983068 · LDS
STERIS Corporation
General Hospital · 637d
Cleared May 31, 2000
ANGIOGRAPHIC CONTRAST MANAGEMENT SYSTEM, MODEL PART A AND PART B
K984231 · DXT
Invasatec
Cardiovascular · 553d
Cleared May 31, 2000
SURGEN VALVE
K990331 · FPA
Tiva Medical
General Hospital · 484d
Cleared May 31, 2000
MODIFICATION TO ACIST CL 100H
K991103 · DXT
Acist Medical Systems
Cardiovascular · 426d
Cleared May 31, 2000
RUSCH EMERGENCY MASK
K993528 · CBP
Rusch, Inc.
Anesthesiology · 226d
Cleared May 31, 2000
QUEST MPS PERFUSION ASSISTED DIRECT CORONARY ARTERY BYPASS (PADCAB)
K994274 · FRN
Quest Medical, Inc.
General Hospital · 163d
Cleared May 30, 2000
NEOCARE 20 MICRON BLOOD FILTER
K000719 · CAK
Whatman, Inc.
General Hospital · 88d
Cleared May 30, 2000
SOMNUS DISPOSABLE TISSUE COAGULATING ELECTRODE AND SOMNUS REUSABLE CONNECTOR...
K000720 · GEI
Somnus Medical Technologies, Inc.
General & Plastic Surgery · 88d
Cleared May 30, 2000
PRIME-DENT VISIBLE LIGHT CURE COMPOSITE RESTORATIVE MATERIAL
K001108 · EBF
Prime Dental Manufacturing, Inc.
Dental · 55d
Cleared May 30, 2000
EAGLE ENDO SPECIMEN RETRIEVAL BAG
K001264 · GCJ
Eagle Endoscopic, Inc.
General & Plastic Surgery · 41d
Cleared May 30, 2000
ARTHROCARE SYSTEM 2000 CONTROLLER, ARTHROCARE SYSTEM 2000 CABLE, ARTHROCARE...
K001302 · GEI
Arthrocare Corp.
General & Plastic Surgery · 36d
Cleared May 30, 2000
SOVEREIGN BIPOLAR INSTRUMENTS
K001330 · GEI
Aesculap, Inc.
General & Plastic Surgery · 33d
Cleared May 30, 2000
BARA-MED, ACRYLIC MONOPLACE HYPERBARIC CHAMBER
K993010 · CBF
Environmental Tectonics Corp.
Anesthesiology · 266d
Cleared May 30, 2000
HM-930 ELECTROSURGICAL UNIT
K993991 · GEI
Hill-Med, Inc.
General & Plastic Surgery · 188d
Cleared May 26, 2000
SWIVEL ELBOW
K000215 · BZD
Engineered Medical Systems
Anesthesiology · 123d
Cleared May 26, 2000
DINAMAP ADVANCED NIBP MODULE
K000500 · DXN
Critikon Company, LLC
Cardiovascular · 102d
Cleared May 26, 2000
MEDIVISION I-VIEW PERSONAL VIDEO DISPLAY
K000669 · GCJ
Medivision Endoscopy
General & Plastic Surgery · 88d
Cleared May 26, 2000
HYSTEROSCOPE OPERATING SHEATH AND INSERT, MODEL 8988.031/.041/.231/.241
K000673 · HIH
Richard Wolf Medical Instruments Corp.
Obstetrics & Gynecology · 88d
Cleared May 26, 2000
WHEELCHAIR, MODELS H001A, 4422
K000738 · IOR
Jackson Company, LLC
Physical Medicine · 80d
Cleared May 26, 2000
RIGID GAS PERMEABLE CONTACT LENS
K000795 · HQD
Polymer Technology
Ophthalmic · 74d