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
84697–84720 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 25, 1999
INTELLISYSTEM II COLOR MONITOR
K993341 · MAV
Merit Medical Systems, Inc.
Cardiovascular · 20d
Cleared Oct 25, 1999
K-ASSAY APO AI
K993345 · DER
Kamiya Biomedical Co.
Chemistry · 20d
Cleared Oct 22, 1999
VENTURE IHO 100 HOME FILL COMPLETE HOME OXYGEN SYSTEM
K983627 · CAW
Invacare Corp.
Anesthesiology · 372d
Cleared Oct 22, 1999
HTU3
K984313 · CBF
Hyox Systems , Ltd.
Anesthesiology · 324d
Cleared Oct 22, 1999
SYNTHES LOCKING RECONSTRUCTION PLATE (LRP) WITH CONDYLAR HEAD
K990637 · NEI
Synthes (Usa)
Dental · 238d
Cleared Oct 22, 1999
SPECTRANETICS LEAD LOCKING DEVICE (LLD) #1, #2, #3 LISTER
K990713 · DRB
Spectranetics Corp.
Cardiovascular · 232d
Cleared Oct 22, 1999
ACCUGUIDE MUSCLE INJECTION MONITOR
K990793 · GXZ
Medtronic Xomed
Neurology · 226d
Cleared Oct 22, 1999
REFLECTION CROSSLINKED UHMWPE ACETABULAR COMPONENTS
K991026 · LPH
Smith & Nephew, Inc.
Orthopedic · 207d
Cleared Oct 22, 1999
SIMS PORTEX EPIDURAL CATHETER, 20G MODEL# 4910-16/17
K992471 · BSO
Sims Portex, Inc.
Anesthesiology · 88d
Cleared Oct 22, 1999
NRC NON-RINSE CONDITIONER
K992519 · EBC
Dentsply Intl.
Dental · 86d
Cleared Oct 22, 1999
D/SENSE II (GREEN-OR) DENTIN DESENSITIZER
K992629 · LBH
Centrix, Inc.
Dental · 86d
Cleared Oct 22, 1999
HOWMEDICA OSTEONICS ACCP SYSTEM CORTICAL SCREWS
K993181 · KWQ
Howmedica Osteonics Corp.
Orthopedic · 29d
Cleared Oct 22, 1999
DRYASOL ACID CONCENTRATE MIX
K993212 · KPO
Diasol, Inc.
Gastroenterology & Urology · 28d
Cleared Oct 22, 1999
PURITAN-BENNETT HELIOS PORTABLE LIQUID OXYGEN SYSTEM
K993220 · BYJ
Puritan Bennett Corp.
Anesthesiology · 25d
Cleared Oct 22, 1999
SORING GMBH, ARCO 3000, ARCO 2000, ARCO 1000, MBC 601, MBC 600
K993265 · GEI
Soring GmbH Medizintechnik
General & Plastic Surgery · 23d
Cleared Oct 21, 1999
ZOLL M SERIES 12SL ANALYSIS OPTION
K991556 · MKJ
Zoll Medical Corp
Cardiovascular · 170d
Cleared Oct 21, 1999
CATHETER INNOVATIONS IMPLANTABLE PORT
K991897 · LJT
Catheter Innovations, Inc.
General Hospital · 139d
Cleared Oct 21, 1999
PACIFIC IMPLANT TITANIUM ENDODONTIC POINT
K992582 · EKL
Pacific Implant, Inc.
Dental · 80d
Cleared Oct 21, 1999
SURGEON POWDER-FREE GLOVES, LATEX, STERILE
K992679 · KGO
Wear Safe Malaysia Sdn. Bhd.
General Hospital · 72d
Cleared Oct 21, 1999
THE BRIGHT MEDICAL DILATION RETRACTOR SYSTEM
K992898 · GZT
Bright Medical Instruments
Neurology · 55d
Cleared Oct 21, 1999
BIO-MODULAR SHOULDER OFFSET HUMERAL HEADS
K992899 · KWS
Biomet, Inc.
Orthopedic · 52d
Cleared Oct 21, 1999
JEL BIOS 10 (CODE NAME RD-1801)
K993136 · EJT
J.F. Jelenko & Co., Inc.
Dental · 31d
Cleared Oct 21, 1999
MEDTRONIC AVE BRIDGE STENT
K993145 · FGE
Medtronic Ave, Inc.
Gastroenterology & Urology · 31d
Cleared Oct 21, 1999
JEL BIOS 18 (CODE NAME RD- 1214)
K993152 · EJT
J.F. Jelenko & Co., Inc.
Dental · 30d