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
81193–81216 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 16, 2000
SURGICAL DYNAMICS SPINAL RETRACTOR
K002008 · HRX
United States Surgical, A Division of...
Orthopedic · 44d
Cleared Aug 16, 2000
WILLI GELLER CREATION & AV PORCELAIN
K002041 · EIH
Jensen Industries, Inc.
Dental · 42d
Cleared Aug 16, 2000
ACUMATCH P-SERIES PRESS-FIT PLASMA, ACUMATCH P-SERIES PRESS-FIT, ACUMATCH...
K002141 · LWJ
Exactech, Inc.
Orthopedic · 30d
Cleared Aug 16, 2000
SLIMCATH-DX MODELS, 3SUXXXX, 3SBXXXX, AND FCXXXX
K993698 · DRF
Mogul Enterprises
Cardiovascular · 288d
Cleared Aug 15, 2000
CHARTER MEDICAL NEONATAL SYRINGE SET
K000685 · BRZ
Charter Medical, Ltd.
General Hospital · 168d
Cleared Aug 15, 2000
SANSIBAR CPAP SYSTEM
K000888 · BZD
Prym Medical , Ltd.
Anesthesiology · 148d
Cleared Aug 15, 2000
NITRILE EXAM GLOVE, POWDER-FREE, COLOR BLUE
K002218 · LZA
Shanghai Champion Plastic Products...
General Hospital · 22d
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