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
83329–83352 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 02, 2000
MULTISAFE POWDERED LATEX EXAMINATION GLOVES, NONSTERILE
K993811 · LYY
Multisafe Sdn. Bhd.
General Hospital · 113d
Cleared Mar 02, 2000
UBAS
K993941 · KWX
Marukin Diagnostics
Chemistry · 104d
Cleared Mar 02, 2000
TOOTHBRUSH WASH
K994144 · EFW
Cal Huech, Inc.
Dental · 86d
Cleared Mar 02, 2000
HYLASHIELD CL
K994170 · MRC
Biomatrix, Inc.
Ophthalmic · 83d
Cleared Mar 02, 2000
PULPDENT CAVITY PREPARATION III
K994180 · LBH
Pulpdent Corp.
Dental · 83d
Cleared Mar 02, 2000
MRI- FLOW ANALYTICAL SOFTWARE PACKAGE
K994282 · LNH
Medis Medical Imaging Systems BV
Radiology · 73d
Cleared Mar 02, 2000
SEPRAMESH BIOSURGICAL COMPOSITE, MODEL SMBC-XXX
K994328 · FTL
Genzyme Corp.
General & Plastic Surgery · 71d
Cleared Mar 01, 2000
MODIFIED HYDROPHILIC COATED GUIDEWIRE
K000011 · DQX
Lake Region Mfg., Inc.
Cardiovascular · 58d
Cleared Mar 01, 2000
MERCURY MEDICAL DISPOSABLE RADIOFREQUENCY CANNULA
K000073 · GXI
Mercury Medical
Neurology · 51d
Cleared Mar 01, 2000
MPT 24 AND VITAL VIEW 24
K000276 · DRG
Criticare Systems, Inc.
Cardiovascular · 30d
Cleared Mar 01, 2000
STAPLETAC2 BONE ANCHOR SYSTEM
K000279 · MBI
American Medical Systems, Inc.
Orthopedic · 30d
Cleared Mar 01, 2000
NAC Y-ADP
K000343 · FPA
The Kipp Group
General Hospital · 27d
Cleared Mar 01, 2000
MDI DS-DNA TEST
K000477 · LRM
Micro Detect, Inc.
Immunology · 16d
Cleared Mar 01, 2000
ADVANTA SUPER SOFT GRAFT
K000499 · DSY
Atrium Medical Corp.
Cardiovascular · 15d
Cleared Mar 01, 2000
ADVANTA SUPER SOFT GRAFT
K000504 · DYF
Atrium Medical Corp.
Cardiovascular · 15d
Cleared Mar 01, 2000
VOCOM IMPLANT- 8MM
K000533 · MIX
Smith & Nephew, Inc.
Ear, Nose, Throat · 13d
Cleared Mar 01, 2000
CROSS LINKED POLYETHYLENE ACETABULAR COMPONENTS,MODEL XX-YY-ZZZZZZ
K990330 · JDI
Implex Corp.
Orthopedic · 393d
Cleared Mar 01, 2000
CHILLBUSTER PORTABLE ELECTRIC BLANKET SYSTEM, MODEL 8001
K991684 · DWJ
Thermogear, Inc.
Cardiovascular · 289d
Cleared Mar 01, 2000
PATIENT CABLES FOR MONITORING, I.E., ECG, EKG, SPO2, AND BP INTERFACE CABLES...
K992524 · DSA
Advantage Medical Electronics, Inc.
Cardiovascular · 217d
Cleared Mar 01, 2000
LEMAITRE VENOUS THROMBECTOMY CATHETER
K992934 · DXE
Vascutech, Inc.
Cardiovascular · 183d
Cleared Mar 01, 2000
CARDIOPULMONARY BYPASS PUMP TUBING - 1/4 INCH TUBING, CARDIOPULMONARY BYPASS...
K993189 · DWE
Terumo Corp.
Cardiovascular · 160d
Cleared Mar 01, 2000
MIKRO-TIP ANGIOGRAPHIC CATHETER
K993694 · DQO
Millar Instruments, Inc.
Cardiovascular · 120d
Cleared Mar 01, 2000
REFLEX TREATMENT SYSTEM
K994079 · HIR
Deschutes Medical Products, Inc.
Gastroenterology & Urology · 90d
Cleared Mar 01, 2000
SUPERSTITCH
K994087 · OCW
Sutura, Inc.
Gastroenterology & Urology · 89d