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
85009–85032 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 17, 1999
TENS/FES/NMES ELECTRODES
K983097 · GXY
Uni-Patch, Inc.
Neurology · 389d
Cleared Sep 17, 1999
@ TARGET
K983410 · HAW
Brainlab AG
Neurology · 354d
Cleared Sep 17, 1999
OLYMPUS DISTAL ATTACHMENT, MODELS...
K984358 · FDS
Olympus America, Inc.
Gastroenterology & Urology · 284d
Cleared Sep 17, 1999
BIOBUTTON
K990194 · HWC
Linvatec Corp.
Orthopedic · 239d
Cleared Sep 17, 1999
INSTRUMENT, ULTRASONIC, SCALPEL
K990362 · GEI
Ethicon Endo-Surgery, Inc.
General & Plastic Surgery · 224d
Cleared Sep 17, 1999
CALTAG FETAL HEMOGLOBIN TEST
K990641 · GHQ
Caltag Laboratories, Inc.
Hematology · 203d
Cleared Sep 17, 1999
ARGLAES-AB ANTIMICROBIAL BARRIER FILM DRESSING & ISLAND DRESSING
K990810 · FRO
Maersk Medical, Ltd.
General & Plastic Surgery · 190d
Cleared Sep 17, 1999
EXCEL GE BLOOD GLUCOSE TEST STRIPS & CODE STRIP
K991480 · CGA
Selfcare, Inc.
Chemistry · 142d
Cleared Sep 17, 1999
DRX QT. HCG
K991532 · DHA
Metrika, Inc.
Chemistry · 137d
Cleared Sep 17, 1999
MEDI-TEST COMBI 11
K991927 · JIL
Macherey-Nagel-Duren
Chemistry · 101d
Cleared Sep 17, 1999
FUTURA GLASS IONOMER SILVER REINFORCED
K991974 · EMA
Ab Ardent
Dental · 98d
Cleared Sep 17, 1999
GAMMA-B 25-HYDROXY VITAMIN D RIA
K991998 · MRG
Immunodiagnostic Systems , Ltd.
Chemistry · 95d
Cleared Sep 17, 1999
GILTECH PLUS HYDROGEL SKIN DRESSING
K992094 · NAE
Giltech Plus, Inc.
General & Plastic Surgery · 88d
Cleared Sep 17, 1999
MODUS SYSTEM SELF-DRILLING SCREWS
K992106 · HWC
Medartis AG
Orthopedic · 87d
Cleared Sep 17, 1999
PHAZX VLD-100
K992129 · GZO
Phazx Systems, Inc.
Neurology · 86d
Cleared Sep 17, 1999
SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-6000
K992321 · GKP
Dade Behring, Inc.
Hematology · 67d
Cleared Sep 17, 1999
CO2 GAS WARMER II, MODEL 6-800-00
K992381 · HIF
Northgate Technologies, Inc.
Obstetrics & Gynecology · 63d
Cleared Sep 17, 1999
TOTAL HAEMOLYTIC COMPLEMENT RID KIT
K992488 · DAE
The Binding Site, Ltd.
Immunology · 53d
Cleared Sep 17, 1999
OXYGEN ENRICHMENT KIT, MODELS SG 066, SG 067
K992670 · CBK
Instrumentation Industries, Inc.
Anesthesiology · 88d
Cleared Sep 17, 1999
CARDIOPHONICS 1000 MEMORY MONITOR
K992772 · DXH
Rlt Medical Assoc., Inc.
Cardiovascular · 30d
Cleared Sep 17, 1999
LORENZ EXTERNAL MANDIBULAR DISTRACTOR
K992873 · MQN
Walter Lorenz Surgical, Inc.
Dental · 22d
Cleared Sep 17, 1999
COLOR BUFFED CEMENTED FEMORAL
K992903 · JDI
Biomet, Inc.
Orthopedic · 18d
Cleared Sep 16, 1999
FRESH AIR
K981047 · CAW
Colorado Medtech, Inc.
Anesthesiology · 545d
Cleared Sep 16, 1999
BP-TEL TRANS-TELEPHONIC BLOOD PRESSURE MEASUREMENT SYSTEM
K983717 · DXN
Aerotel Medical Systems (1998) , Ltd.
Cardiovascular · 330d