Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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176,076 results
82321–82344 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 15, 2000
NITRILE EXAM GLOVE, PRE-POWDERED, COLOR BLUE
K002220 · LZA
Shanghai Champion Plastic Products...
General Hospital · 22d
Cleared Aug 15, 2000
SURGICAL DRAPES
K002419 · KKX
Allegiance Healthcare Coporation
General Hospital · 7d
Cleared Aug 15, 2000
V QUICK PATCH
K993934 · DRX
Vq Corp.
Cardiovascular · 271d
Cleared Aug 14, 2000
BIOGEL NEOTECH II POWDER-FREE NEOPRENE SURGEON'S GLOVE
K000421 · KGO
Ssl Americas, Inc. (Regent Medical)
General Hospital · 188d
Cleared Aug 14, 2000
NEOLUS NEEDLE
K001572 · FMI
Terumo Europe N.V.
General Hospital · 84d
Cleared Aug 14, 2000
DANA DIABECARE
K001604 · LZG
Sooil Development Co., Ltd.
General Hospital · 82d
Cleared Aug 14, 2000
BABY DOPPLEX 4000 (BD4000)
K001677 · HGM
Huntleigh Diagnostics , Ltd.
Obstetrics & Gynecology · 74d
Cleared Aug 14, 2000
URISITE URINE COLLECTION KIT FOR MICROALBUMIN/CREATININE TESTING
K001810 · JIR
Flexsite Diagnostics, Inc.
Chemistry · 60d
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