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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
128761–128784 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 12, 1989
REVISED LABELING FOR ARTERIAL EMBOLECTOMY CATHETER
K894681 · DXE
Shiley, Inc.
Cardiovascular · 79d
Cleared Oct 12, 1989
OMNIFIT CERAMIC MORSE TAPER HEAD
K894694 · LZO
Osteonics Corp.
Orthopedic · 80d
Cleared Oct 12, 1989
VASCULAR GRAFT PACKAGE (SHELF-LIFE EXTENSION)
K894732 · DSY
Medtronic Vascular
Cardiovascular · 78d
Cleared Oct 12, 1989
PRECEPT-GT(TM) MICROSENSOR PRESSURE MONITOR CATH.
K894747 · DXO
Endosonics Corp.
Cardiovascular · 78d
Cleared Oct 12, 1989
CARE 5000 SYSTEM
K894858 · DSI
Care Systems, Inc.
Cardiovascular · 73d
Cleared Oct 12, 1989
PERLIDENT
K894933 · EJR
Germiphene Corp.
Dental · 70d
Cleared Oct 12, 1989
DISPOSABLE PLASTIC VAGINAL SPECULA
K894957 · HIB
Zinnanti Surgical Instruments, Inc.
Obstetrics & Gynecology · 66d
Cleared Oct 12, 1989
ALTERNATE PACKAGING CONF. OF PACEMAKER LEAD ADAP.
K894976 · DTD
Medtronic Vascular
Cardiovascular · 66d
Cleared Oct 12, 1989
CIBA CORNING MAGIC LITE PROLACTIN IMMUNOASSAY
K894988 · CFT
Ciba Corning Diagnostics Corp.
Chemistry · 65d
Cleared Oct 12, 1989
ZOLL PD 2200 PACING-DEFIBRILLATION ELECTRODES
K895032 · LDD
Zmi Corp.
Cardiovascular · 65d
Cleared Oct 12, 1989
AI5200 DIAGNOSTIC ULTRASOUND SYSTEM TRANSDUCER
K895071 · IYO
Acoustic Imaging
Radiology · 62d
Cleared Oct 12, 1989
R2 PACE ADAPTOR CABLE, MODEL 196
K895728 · DRO
Darox Corp.
Cardiovascular · 17d
Cleared Oct 12, 1989
R2 PACE PAD, MODEL 480
K895729 · DRO
Darox Corp.
Cardiovascular · 17d
Cleared Oct 11, 1989
HUMIDI-FLEX TM
K885313 · BYD
Life Design Systems, Inc.
Anesthesiology · 286d
Cleared Oct 11, 1989
MODIFIED SUTURE USED IN CATHETER INSERTION TRAYS
K892450 · KGX
Quinton, Inc.
General & Plastic Surgery · 184d
Cleared Oct 11, 1989
SURGEON'S GLOVES
K892495 · KGO
Care-Pro Industries, Inc.
General Hospital · 181d
Cleared Oct 11, 1989
SAFETY SURGEONS GLOVES
K892499 · KGO
Advance Rubber, Inc.
General Hospital · 180d
Cleared Oct 11, 1989
PNEUMOTHORAX KIT, MOTIFICATION
K892640 · JDL
Arrow Intl., Inc.
Orthopedic · 182d
Cleared Oct 11, 1989
STUART CD UNIVERSAL ROD CONNECTOR CLAMPS
K894702 · KWP
Bio-Medical Prosthetics
Orthopedic · 76d
Cleared Oct 11, 1989
HT-RES RTP SYSTEM
K894706 · IYE
Adac Laboratories
Radiology · 79d
Cleared Oct 11, 1989
CUSTOM IN-THE-CANAL (ITC) HEARING AID MODEL I54
K895140 · ESD
Oticon Corp.
Ear, Nose, Throat · 56d
Cleared Oct 10, 1989
OVERDENTURE ATTACHMENT
K891613 · DZE
Implant Innovations International, Inc.
Dental · 204d
Cleared Oct 10, 1989
GREENLEAF HAND IMPAIRMENT EVALUATION SYSTEM
K893537 · LBB
Greenleaf Medical Systems, Inc.
Neurology · 155d
Cleared Oct 10, 1989
HYDRAULIC IV POLE
K893597 · FOX
Arthro-Medic, Inc.
General Hospital · 154d