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
83785–83808 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 20, 2000
REVELATION POROUS HIP STEM
K994070 · LPH
Encore Orthopedics, Inc.
Orthopedic · 49d
Cleared Jan 20, 2000
SMITH & NEPHEW XENON LIGHT SOURCES AND ACCESSORIES
K994084 · FFS
Smith & Nephew, Inc.
Gastroenterology & Urology · 48d
Cleared Jan 20, 2000
DIMENSION TOTAL IRON BINDING CAPACITY (IBCT) CALIBRATOR
K994114 · JIS
Dade Behring, Inc.
Chemistry · 45d
Cleared Jan 20, 2000
STELLARTECH RADIOFREQUENCY GENERATOR,MODEL 1025A-115, STELLARTECH...
K994173 · GEI
Stellartech Research Corp.
General & Plastic Surgery · 41d
Cleared Jan 20, 2000
OLYMPUS CREATINE KINASE REAGENT OSR6179/6279
K994189 · CGS
Olympus Diagnostica GmbH
Chemistry · 38d
Cleared Jan 20, 2000
SENSI-PRO DISPOSABLE POWDER FREE SYNTHETIC VINYL PATIENT EXAMINATION GLOVES...
K994258 · LYZ
Shinemound Enterprise, Inc.
General Hospital · 34d
Cleared Jan 20, 2000
MODEL 1000 HOLMIUM LASER SYSTEM
K994273 · GEX
New Star Lasers, Inc.
General & Plastic Surgery · 31d
Cleared Jan 19, 2000
SONOACE 600 DIAGNOSTIC ULTRASOUND SYSTEM
K000030 · IYO
Medison America, Inc.
Radiology · 14d
Cleared Jan 19, 2000
WATCH STYLE WRIST DIGITAL BLOOD PRESSURE MONITOR, MODEL: KLOCK
K991545 · DXQ
Industrielle Entwicklung...
Cardiovascular · 261d
Cleared Jan 19, 2000
INTER-OS BONE GENERATOR
K993869 · MQN
Inter-Os Technologies, LLC
Dental · 65d
Cleared Jan 18, 2000
MULTIFUNCTION KEITO K5
K984083 · DXN
Bumedco Intl., Inc.
Cardiovascular · 428d
Cleared Jan 18, 2000
LPG THERAPEUTIC MASSAGER, MODELS -ESI, THERAPEUTIC MASSAGER/VIBRATOR
K990445 · ISA
Lpg USA, Inc.
Physical Medicine · 342d
Cleared Jan 18, 2000
1.5 M PROPANEDIOL FREEZING MEDIUM, 1.5 PROPANEDIOL 0.1 SUCROSE FREEZING...
K991390 · MQL
Sage Biopharma
Obstetrics & Gynecology · 272d
Cleared Jan 18, 2000
1ST RESPONSE INFANT MANUAL RESUSCITATOR, BAG RESEVOIR, 1ST RESPONSE PEDIATRIC...
K991861 · BTM
Sims Portex, Inc.
Anesthesiology · 231d
Cleared Jan 18, 2000
3.0 ML RESERVOIR, MODEL 103/193
K991936 · FRN
Medtronic Minimed
General Hospital · 223d
Cleared Jan 18, 2000
V.A.C. PLUS
K992448 · OMP
Kinetic Concepts, Inc.
General & Plastic Surgery · 180d
Cleared Jan 18, 2000
A-22 HEMODIALYZER
K992563 · KDI
Althin Medical AB
Gastroenterology & Urology · 169d
Cleared Jan 18, 2000
AF-180 HEMODIALYZER
K992564 · KDI
Althin Medical AB
Gastroenterology & Urology · 169d
Cleared Jan 18, 2000
AF-150 HEMODIALYZER
K992566 · KDI
Althin Medical AB
Gastroenterology & Urology · 169d
Cleared Jan 18, 2000
AF-220 HEMODIALYZER
K992573 · KDI
Althin Medical AB
Gastroenterology & Urology · 169d
Cleared Jan 18, 2000
OSOM ULTRA STREP A TEST, MODEL 147
K992658 · GTY
Wyntek Diagnostics, Inc.
Microbiology · 162d
Cleared Jan 18, 2000
THE BI-DIRECTIONAL SPIRAL & EPOXY ROOT CANAL CEMENT SYSTEM
K992727 · KIF
Mds
Dental · 158d
Cleared Jan 18, 2000
TRANSDUCERS FOR ULTRASOUND AND TOCODYNAMOMETER FETAL MONITORING
K992811 · HFM
Epic Medical Equipment Services, Inc.
Radiology · 151d
Cleared Jan 18, 2000
GYNECARE VERSAPOINT G-VAP ELECTRODE
K992901 · HIH
Gynecare, Inc.
Obstetrics & Gynecology · 141d