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
91129–91152 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 20, 1998
ARGOSY PROGRAMMABLE ONQUE
K974242 · ESD
Argosy Electronics
Ear, Nose, Throat · 69d
Cleared Jan 20, 1998
KERATOME SYSTEM
K974243 · HMY
Insight Technologies Instruments, LLC
Ophthalmic · 69d
Cleared Jan 20, 1998
ALCON CONTACT LENS CASE
K974281 · LRX
Alcon Laboratories
Ophthalmic · 67d
Cleared Jan 20, 1998
DIGITAL TINNITUS MASKING SYSTEM
K974501 · KLW
Petroff Audio Technologies
Ear, Nose, Throat · 53d
Cleared Jan 20, 1998
HEWLETT-PACKARD M2605A VIRIDIA WAVE VIEWER
K974567 · MSX
Hewlett-Packard Co.
Cardiovascular · 46d
Cleared Jan 20, 1998
PHACOPAK
K974719 · HQC
Paradigm Medical Industries, Inc.
Ophthalmic · 33d
Cleared Jan 16, 1998
DUAL INTEGRATOR DENTAL IMPLANT ACCESSORIES PARALLEL PIN, DEPTH GAGE, AND...
K970572 · DZE
Implant Integration Systems, Inc.
Dental · 336d
Cleared Jan 16, 1998
EMBLA
K971813 · OLV
Ferguson Medical
Neurology · 245d
Cleared Jan 16, 1998
HOME CARE BEAD BED
K972176 · INX
Kinetic Concepts, Inc.
Physical Medicine · 221d
Cleared Jan 16, 1998
REVEAL INSERTABLE LOOP RECORDER (ILR) SYSTEM
K972242 · MXC
Medtronic Vascular
Cardiovascular · 214d
Cleared Jan 16, 1998
AESCULAP CRANIOFIX TITANIUM CLAMP SYSTEM
K972332 · GXN
Aesculap, Inc.
Neurology · 207d
Cleared Jan 16, 1998
BIPOLAR ELECTROSURGICAL PENCIL, STRAIGHT AND ANGLED
K972562 · GEI
Electroscope, Inc.
General & Plastic Surgery · 191d
Cleared Jan 16, 1998
SERVOTRONIC EC100 SYSTEM
K972857 · HBC
Medicon EG
Neurology · 168d
Cleared Jan 16, 1998
OSTEONICS SCORPIO TOTAL KNEE UNIVERSAL DOME PATELLAR COMPONENT
K972967 · JWH
Osteonics Corp.
Orthopedic · 158d
Cleared Jan 16, 1998
SPACEMAKER SURGICAL BALLOON DISSECTOR, SPACEMAKER II SURGICAL BALLOON...
K973046 · GCJ
General Surgical Innovations
General & Plastic Surgery · 154d
Cleared Jan 16, 1998
VILEX CANNULATED BONE SCREW, DUVAL CANNULATED BONE SCREW
K973309 · HWC
Vilex, Inc.
Orthopedic · 135d
Cleared Jan 16, 1998
ATRION MEDICAL PRODUCTS LACRIMAL INTUBATION SET
K973633 · OKS
Atrion Medical Products, Inc.
Ophthalmic · 183d
Cleared Jan 16, 1998
POWDER FREE PATIENT EXAMINATION GLOVE SAFE GLOVE
K973830 · LYY
Safe Glove , Ltd.
General Hospital · 101d
Cleared Jan 16, 1998
RAC 2A MODULE HOUSING
K973984 · CCK
Marquette Medical Systems, Inc.
Anesthesiology · 88d
Cleared Jan 16, 1998
METRON QA-510 SPO2 ANALYZER
K973991 · DQA
Metron U.S., Inc.
Anesthesiology · 87d
Cleared Jan 16, 1998
ADVANTAGE EMG SYSTEM, MODEL #A100
K974010 · IKN
Advantage Medical Division of Cme...
Neurology · 87d
Cleared Jan 16, 1998
TIMESH SYSTEM
K974017 · HRS
Sofamor Danek USA,Inc.
Orthopedic · 86d
Cleared Jan 16, 1998
RECHARGEABLE BATTERY PART NUMBER GL825-200
K974061 · DXN
Alexander Mfg. Co.
Cardiovascular · 81d
Cleared Jan 16, 1998
STARLIGHT PULSED DIODE ARRAY LASER SYSTEM
K974346 · GEX
Star Medical Technologies, Inc.
General & Plastic Surgery · 58d