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
82825–82848 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Mar 01, 2000
MEDAMICUS EPIDURAL INTRODUCER
K994097 · GZB
Medamicus, Inc.
Neurology · 89d
Cleared Mar 01, 2000
PERCUTX-INJECTION/ASPIRATION NEEDLE PROBES/DEVICES
K994151 · GAA
Ximed/Prosure/Injectx
General & Plastic Surgery · 83d
Cleared Mar 01, 2000
PHALANGEAL FIXATION SYSTEM
K994232 · HTY
Medcanica, Inc.
Orthopedic · 76d
Cleared Mar 01, 2000
DIMENSION SPECIAL PROTEIN CALIBRATOR
K994291 · JIT
Dade Behring, Inc.
Immunology · 71d
Cleared Mar 01, 2000
DIMENSION C4 FLEX REAGENT CARTRIDGE
K994293 · DBI
Dade Behring, Inc.
Immunology · 71d
Cleared Mar 01, 2000
DIMENSION C3 FLEX REAGENT CARTRIDGE
K994296 · CZW
Dade Behring, Inc.
Immunology · 71d
Cleared Mar 01, 2000
OVUM PICK-UP NEEDLES WITH AQ COATING, ASPIRATION NEEDLES WITH AQ COATING
K994417 · MQE
Cook Urological, Inc.
Obstetrics & Gynecology · 63d
Cleared Feb 29, 2000
SYNTHETIC POWDER FREE (WHITE) VINYL PATIENT EXAMINATION GLOVES
K000071 · LYZ
Shijiazhuang Great Eagle Plastic...
General Hospital · 50d
Cleared Feb 29, 2000
HARDYDISK, NALIDIXIC ACID, 30MCG
K000130 · JTN
Hardy Diagnostics
Microbiology · 42d