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
81721–81744 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 14, 2000
MILLENNIUM 9000 PHASED ARRAY NEUROVASCULAR COIL
K001870 · MOS
Usa Instruments, Inc.
Radiology · 55d
Cleared Aug 14, 2000
HAC-300 HEAD ARRAY COIL
K001944 · MOS
Mri Devices Corp.
Radiology · 49d
Cleared Aug 14, 2000
PVP-POLYVINYLPYRROLIDONE REAGENT, MODEL CAT#2210
K001967 · MQL
Invitrocare, Inc.
Obstetrics & Gynecology · 47d
Cleared Aug 14, 2000
RUBBERCARE POLYMER-CHLORINATED POWDER-FREE GUARDIAN POLYMER-CHLORINATED...
K002112 · LYY
Perusahaan Pelindung Getah (M) Sdn Bhd
General Hospital · 33d
Cleared Aug 14, 2000
PAIN CARE 2000L
K002321 · MEB
Breg, Inc.
General Hospital · 14d
Cleared Aug 14, 2000
BIO-BLOCKS
K970569 · LYC
Geistlich-Pharma
Dental · 1294d
Cleared Aug 14, 2000
DIALGUARD ENDOTOXIN REMOVAL DEVICE
K993806 · FIP
Clarigen, Inc.
Gastroenterology & Urology · 279d
Cleared Aug 14, 2000
OSMANTHUS, KONGFU, AND GOBON, NATURAL RUBBER LATEX CONDOMS
K994118 · HIS
Guilin Latex Factory
Obstetrics & Gynecology · 252d
Cleared Aug 14, 2000
INSTANT-VIEW COCAINE (BENZYLECGONINE) URINE DIP STRIP TEST
K994403 · DIO
Alfa Scientific Designs, Inc.
Toxicology · 230d
Cleared Aug 14, 2000
INSTANT-VIEW METHAMPHETAMINE URINE DIP STRIP TEST
K994406 · DJC
Alfa Scientific Designs, Inc.
Toxicology · 230d
Cleared Aug 11, 2000
MAGIC MOBILITY 4 X 4 WHEELCHAIR
K000796 · ITI
Vestil Manufacturing Corp.
Physical Medicine · 151d
Cleared Aug 11, 2000
MICOR ANESTHESIA CONDUCTION KIT
K001940 · CAZ
Micor, Inc.
Anesthesiology · 46d
Cleared Aug 11, 2000
RUBBERCARE GUARDIAN POLYMER-COATED POWDER-FREE LATEX EXAMINATION GLOVES:...
K002114 · LYY
Perusahaan Pelindung Getah (M) Sdn Bhd
General Hospital · 30d
Cleared Aug 11, 2000
GDC ULTRASOFT COIL
K002181 · HCG
Boston Scientific, Target
Neurology · 23d
Cleared Aug 11, 2000
NITRILE EXAMINATION GLOVE, PRE-POWDERED, COLOR WHITE
K002216 · LZA
Shanghai Champion Plastic Products...
General Hospital · 18d
Cleared Aug 11, 2000
NITRILE EXAM GLOVE, POWDER-FREE, COLOR WHITE
K002217 · LZA
Shanghai Champion Plastic Products...
General Hospital · 18d
Cleared Aug 11, 2000
BMT ANSCORE HEALTH MANAGEMENT SYSTEM
K993875 · DPS
Boston Medical Technologies, Inc.
Cardiovascular · 270d
Cleared Aug 11, 2000
NIPROTECT POWDER-FREE NITRILE EXAMINATION GLOVES
K994124 · LZA
Mapa Professional
General Hospital · 248d
Cleared Aug 10, 2000
RS-4M+MUSCLE STIMULATOR
K000114 · IPF
Rs Medical
Physical Medicine · 209d
Cleared Aug 10, 2000
POWDER FREE LATEX PATIENT EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (50...
K000913 · LYY
Handsafe Products Sdn. Bhd.
General Hospital · 141d
Cleared Aug 10, 2000
CARDIOSET (HARDWARE), MODEL HO4
K001091 · DXH
Next Millennium Software Solutions, Inc.
Cardiovascular · 128d
Cleared Aug 10, 2000
SIGMA DIAGNOSTICS INFINITY GLUCOSE REAGENT, MODELS 17-25, 17-100P, 17-500P,...
K001403 · CFR
Sigma Diagnostics, Inc.
Chemistry · 99d
Cleared Aug 10, 2000
THE FUGO BLADE
K001498 · NCR
Medisurg , Ltd.
Ophthalmic · 87d
Cleared Aug 10, 2000
ULTIMA METAL-ON-METAL ACETABULAR CUP
K001523 · KWA
DePuy Orthopaedics, Inc.
Orthopedic · 86d