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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
106033–106056 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 20, 1994
N LATEX RF
K942328 · DHR
Behring Diagnostics, Inc.
Immunology · 168d
Cleared Oct 20, 1994
KODAK EXTACHEM CLINICAL CHEMISTRY SLIDE DIGOXIN (DGXN)
K942610 · LFM
Eastman Kodak Company
Chemistry · 140d
Cleared Oct 20, 1994
CEDIA T4 MAB ASSAY
K943019 · KLI
Microgenics Corp.
Chemistry · 118d
Cleared Oct 20, 1994
SEALITE SCIENCE, INC. AQUALITE(R) LH
K943188 · CEP
Sealite Sciences, Inc.
Chemistry · 107d
Cleared Oct 20, 1994
DMA GLUCOSE (OXIDASE) PROCEDURE
K943241 · CGA
Data Medical Associates, Inc.
Chemistry · 106d
Cleared Oct 20, 1994
TRACKER 2/TRACKER 3 HOLTER RECORDER
K943278 · DSH
Reynolds Medical , Ltd.
Cardiovascular · 105d
Cleared Oct 20, 1994
COHORT AVB RETRACTOR SYSTEM
K943472 · HXB
Cohort Medical Products Group, Inc.
Orthopedic · 93d
Cleared Oct 20, 1994
FEDELITY F495, VIENNATONE ALPP II
K943687 · ESD
Starkey Laboratories, Inc.
Ear, Nose, Throat · 83d
Cleared Oct 20, 1994
MRX MICROPLATE READER
K943701 · JJQ
Dynatech Laboratories, Inc.
Chemistry · 83d
Cleared Oct 20, 1994
LIFE TRACE FETAL SPIRAL ELECTRODE WITH MATERNAL REFERENCE
K943732 · HGP
Graphic Controls Corp.
Obstetrics & Gynecology · 79d
Cleared Oct 20, 1994
MELAFOCON A/RIGID GAS PERM CONTACT LEN FOR DAILY WEAR
K943784 · HQD
Menicon Co, Ltd.
Ophthalmic · 86d
Cleared Oct 20, 1994
SAFESTART VASCULAR ACCESS START KIT
K943941 · LRS
Becton Dickinson Vascular Access, Inc.
General & Plastic Surgery · 69d
Cleared Oct 20, 1994
UV CURED METHYL METHACRYLATE HEARING AID SHELL MATERIALS
K943960 · ESD
Miracle-Ear, Inc.
Ear, Nose, Throat · 66d
Cleared Oct 20, 1994
DUPONT ACA PLUS LUTEINIZING HORMONE (LH) METHOD
K943996 · CEP
Dupont Medical Products
Toxicology · 65d
Cleared Oct 20, 1994
AVL OPTI PH/BLOOD GAS ANALYZER
K944089 · CHL
Avl Scientific Corp.
Chemistry · 59d
Cleared Oct 20, 1994
IMAGYN LAPAROSCOPIC INSTRUMENTS
K944129 · HET
Imagyn Medical, Inc.
Obstetrics & Gynecology · 57d
Cleared Oct 20, 1994
BELTONE CONCERTO S
K944502 · ESD
Beltone Electronics Corp.
Ear, Nose, Throat · 36d
Cleared Oct 20, 1994
REDA LAPAROSCOPIC INSTRUMENTS GER-MAIN PRIME ENDO LAPAROSCOPIC INSTRUMENTS
K944706 · GEI
Reda Instrumente GmbH
General & Plastic Surgery · 27d
Cleared Oct 20, 1994
MULTIPLE ED1600 SERIES RADIATION SHIELDS
K944772 · EAK
Image Diagnostics, Inc.
Radiology · 23d
Cleared Oct 20, 1994
WIDEX MODEL LX-ITE
K944838 · ESD
Widex Hearing Aid Co., Inc.
Ear, Nose, Throat · 20d
Cleared Oct 19, 1994
DRIED GRAM-POSITIVE MIC/COMBO PANELS, AMP/EXT DIL
K934323 · JWY
Baxter Diagnostics, Inc.
Microbiology · 411d
Cleared Oct 19, 1994
J.B.S. IMPLANTABLE SPINAL FIXATION DEVICE
K935113 · KWP
J.B.S., S.A.
Orthopedic · 359d
Cleared Oct 19, 1994
MEMOTHERM 10 BABY THERMOMETER
K935280 · FLL
International Regulatory Consultants
General Hospital · 350d
Cleared Oct 19, 1994
INNOVASIVE SUTURE BONE FASTENER WITH SUTURE
K935321 · JDR
Innovasive Devices, Inc.
Orthopedic · 349d