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
141289–141312 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 31, 1986
A549 (HUMAN LUNG CARCINOMA) CULTURE CELLS
K864776 · KIR
Bartels Immunodiagnostic Supplies, Inc.
Pathology · 23d
Cleared Dec 31, 1986
ALANINE AMINO TRANSFERASE ALT/SGPT
K864906 · CKA
Tech-Co, Inc.
Chemistry · 16d
Cleared Dec 31, 1986
BECKMAN DRI-STAT TRIGLYCERIDES-GPO REAGENT KIT
K864939 · CDT
Beckman Instruments, Inc.
Chemistry · 15d
Cleared Dec 30, 1986
MEDSURG VASCULAR ACCESS PORT INFUSION TRAY
K864495
Medsurg Industries, Inc.
General & Plastic Surgery · 46d
Cleared Dec 30, 1986
PAMITEX,LONG LOVE,DESIRE,SKIN LESS,GINZA,LOVE TIME
K864570 · HIS
Dongkuk Techco Rubber Industries
Obstetrics & Gynecology · 40d
Cleared Dec 30, 1986
ELLISON ARTHROSCOPY CHEATER
K864892 · HRX
Buckman Co., Inc.
Orthopedic · 15d
Cleared Dec 29, 1986
HYDROXYLAPATITE BONE GRAFT MATERIAL
K863237 · LYC
Richards Medical Co., Inc.
Dental · 130d
Cleared Dec 29, 1986
FMS MODEL 110
K863736 · IYM
Flir Medical Systems
Radiology · 97d
Cleared Dec 29, 1986
ADA-1000 (ADVANCED DIGITAL ARRAY)
K863780 · IYO
Diasonics, Inc.
Radiology · 94d
Cleared Dec 29, 1986
MLC ENDOTHELIAL CELL COUNTER
K863970 · HJO
Mlc Technologies
Ophthalmic · 76d
Cleared Dec 29, 1986
HERCON ANTISEPTIC TRANSPARENT DRESSING
K864076 · KGX
Hercon Laboratories Corp.
General & Plastic Surgery · 70d
Cleared Dec 29, 1986
MINIMED MODEL 404-S EXTERNAL INFUSION PUMP
K864138 · FRN
Medtronic Minimed
General Hospital · 69d
Cleared Dec 29, 1986
NEOPROBE PORTABLE RADIOISOTOPE DETECTOR
K864263 · IZD
Neoprobe Corp.
Radiology · 61d
Cleared Dec 29, 1986
TRICOTEX WOUND CONTACT LAYER DRESSING
K864264 · NAB
Smith & Nephew, Inc.
General & Plastic Surgery · 61d
Cleared Dec 29, 1986
MUSCLE MASTER (MEDIUM VOLTAGE STIMULATOR)
K864284 · IPF
Modern Systems Technology, Inc.
Physical Medicine · 60d
Cleared Dec 29, 1986
DISPOSAL SURGICAL INSTRUMENTS FOR OPHTHALMOLOGY
K864292 · HNQ
Eye-Ko, Inc.
Ophthalmic · 59d
Cleared Dec 29, 1986
U66 EMS
K864558 · IPF
Suntec Health & Fitness Group, Inc.
Physical Medicine · 59d
Cleared Dec 29, 1986
FLUOROVISION CONTRAST ENHANCER
K864584 · JAA
Digivision, Inc.
Radiology · 39d
Cleared Dec 29, 1986
MYOPAC (TM), MODEL 9600
K864625 · IPF
Medical Devices, Inc.
Physical Medicine · 34d
Cleared Dec 29, 1986
KC/EMG DIAGNOSTIC ELECTROMYOGRAPH
K864630 · IKN
Chattanooga Group, Inc.
Neurology · 34d
Cleared Dec 29, 1986
REUSABLE SURGICAL KERATOSCOPE
K864639 · HLR
Jedmed Instrument Co.
Ophthalmic · 33d
Cleared Dec 29, 1986
MODEL 2060 W/6 CM(2) & MODEL 2100 W/10 CM(2) TRANS
K864653 · IMJ
Rich-Mar Corp.
Physical Medicine · 31d
Cleared Dec 29, 1986
HEYER-SCHULTE HERMETIC EXTERNAL CSF DRAIN. SYSTEM
K864676 · JXG
American V. Mueller
Neurology · 27d
Cleared Dec 29, 1986
VARIOUS SYRINGES W/NEEDLES, W/OUT NEEDLES, NEEDLES
K864747 · FMF
Jms Co., Ltd.
General Hospital · 24d