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.

175,218 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,724 results
68305–68328 of 174,724
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 26, 2004
ICON POLYAXIAL PEDICLE SCREW SYSTEM
K033090 · KWP
Alphatec Mfg., Inc.
Orthopedic · 179d
Cleared Mar 26, 2004
PRIZM KERATOME BLADE, MODEL MK8512M2
K033236 · HNO
Surgin Surgical Instrumentation, Inc.
Ophthalmic · 172d
Cleared Mar 26, 2004
CHEETAH WHEELCHAIR
K033460 · IOR
R82 A/S
Physical Medicine · 148d
Cleared Mar 26, 2004
CLEARFIL PHOTO CORE PLT
K033970 · EBF
Kuraray Medical, Inc.
Dental · 95d
Cleared Mar 26, 2004
NMT MEDICAL TRANSSEPTAL SHEATH SET, MODELS TSS-10-HSC, TSS-11-HSC, TSS12-HSC
K034025 · DYB
Nmt Medical, Inc.
Cardiovascular · 88d
Cleared Mar 26, 2004
CONTOUR SE MICROSPHERES
K034068 · KRD
Boston Scientific Corp
Cardiovascular · 86d
Cleared Mar 26, 2004
VERTEBRON SCP CERVICAL PLATE SYSTEM
K040003 · KWQ
Vertebron, Inc.
Orthopedic · 84d
Cleared Mar 26, 2004
MODIFICATION TO MODULAR REPLACEMENT SYSTEM (MRS) HUMERAL STEMS
K040128 · HSD
Howmedica Osteonics Corp.
Orthopedic · 65d
Cleared Mar 26, 2004
ANTERIOR LUMBAR BUTTRESS SYSTEM
K040130 · KWQ
Seaspine
Orthopedic · 65d
Cleared Mar 26, 2004
CERASORB M ORTHO
K040216 · MQV
Curasan AG
Orthopedic · 56d
Cleared Mar 26, 2004
LOW PROFILE LUTHER SAFETY HUBER
K040527 · FPA
Luther Needlesafe Products, Inc.
General Hospital · 25d
Cleared Mar 26, 2004
ALOKA MODEL SSD-4000 DIAGNOSTIC ULTRASOUND SYSTEM W/OPTIONAL SONOREAL 3D...
K040719 · IYO
Aloka Co., Ltd.
Radiology · 7d
Cleared Mar 25, 2004
INVACARE POLARIS EX HEATED HUMIDIFIER, MODEL ISP4000
K031176 · BTT
Invacare Corp.
Anesthesiology · 346d
Cleared Mar 25, 2004
NOVABONE-BBG-RESORBABLE BONE GRAFT SUBSTITUTE
K033994 · LYC
Novabone Products, LLC
Dental · 92d
Cleared Mar 25, 2004
PRECISION VPS IMPRESSION MATERIAL
K040053 · ELW
Discus Dental, Inc.
Dental · 73d
Cleared Mar 25, 2004
HEMORRHAGE OCCLUDER PIN
K040109 · GDW
Tools For Surgery, LLC
General & Plastic Surgery · 65d
Cleared Mar 25, 2004
MONITECT MDMA DRUG SCREEN CASSETTE TEST, MODEL MC22
K040203 · DKZ
Branan Medical Corp.
Toxicology · 56d
Cleared Mar 25, 2004
WAKO AUTO KIT PREALBUMIN, WAKO AUTOKIT PREALBUMIN CALIBRATOR SET, PREALBUMIN...
K040226 · JIT
Wako Chemicals USA, Inc.
Chemistry · 52d
Cleared Mar 25, 2004
TENDERWET ACTIVE
K040517 · MGQ
Medline Industries, Inc.
General & Plastic Surgery · 27d
Cleared Mar 25, 2004
POLYETHER URETHANE MATERIAL CHANGE IN NEUROSTIMULATION LEADS
K040568 · GZB
Medtronic Vascular
Neurology · 21d
Cleared Mar 25, 2004
RAPID PROGRAMMER
K040609 · GZB
Advanced Neuromodulation Systems
Neurology · 17d
Cleared Mar 25, 2004
LED TURBO
K040618 · EBZ
Apoza Enterprise Co., Ltd.
Dental · 16d
Cleared Mar 25, 2004
PRECISION LINK DIABETES DATA MANAGEMENT SYSTEM
K040628 · NBW
Abbott Laboratories
Chemistry · 15d
Cleared Mar 25, 2004
MODIFICATION TO TRUETRACK SMART SYSTEM BLOOD GLUCOSE METER, TEST STRIPS AND...
K040670 · NBW
Home Diagnostics, Inc.
Chemistry · 10d