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
147001–147024 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 22, 1985
IMAGE-IGE
K853025 · DGC
Clinical Reference Laboratory, Inc.
Immunology · 35d
Cleared Aug 22, 1985
MODEL 372L HEARING AID
K853108 · ESD
Telex Communications, Inc.
Ear, Nose, Throat · 30d
Cleared Aug 22, 1985
APO-CHROME IMMUNOASSAY TEST SET FOR APOLIPOPROTEIN
K853174 · MSJ
Photec Diagnostics, Inc.
Immunology · 23d
Cleared Aug 22, 1985
CANNON BABYSAFE NIPPLE SHIELDS
K853176 · HFS
Medela, Inc.
General Hospital · 41d
Cleared Aug 22, 1985
MIC JEJUNAL FEEDING TUBE
K853197 · KNT
Medical Innovations Corp.
Gastroenterology & Urology · 23d
Cleared Aug 22, 1985
LASER RBP LASER(RETINOL BINDING PROTEIN REAGENTS)
K853261 · CZS
Behring Diagnostics, Inc.
Immunology · 20d
Cleared Aug 22, 1985
VACCESS TM 4006
K853283 · LFJ
Vas-Cath of Canada , Ltd.
Gastroenterology & Urology · 17d
Cleared Aug 22, 1985
MULTISET 40
K853386 · BRZ
Migada, Ltd.
General Hospital · 10d
Cleared Aug 22, 1985
ET - EXTENSION SETS
K853387 · FPA
Migada, Ltd.
General Hospital · 10d
Cleared Aug 22, 1985
MONOSTICON UNI-DOT
K853388 · KTN
Organon, Inc.
Immunology · 9d
Cleared Aug 21, 1985
OMS/GONVERS RETINAL PERFORATOR
K844448 · HNM
Optical Micro Systems, Inc.
Ophthalmic · 278d
Cleared Aug 21, 1985
ORTHOPEDIC CUSTOM SURGICAL KIT
K844595 · LXH
Xanmed Corp.
Orthopedic · 268d
Cleared Aug 21, 1985
BIO-TENS
K844618 · GZJ
Bio-Research Associates, Inc.
Neurology · 267d
Cleared Aug 21, 1985
CESIUM 137 ENDOMETRIAL SOURCE
K850433 · KXK
Syncor Intl. Corp.
Radiology · 198d
Cleared Aug 21, 1985
RADIOISOTOPE CALIBRATOR MODEL 34-062
K850815 · KPT
Victoreen, Inc.
Radiology · 174d
Cleared Aug 21, 1985
INFRARAX DEVICE
K850852 · ILY
Medicon, Inc.
Physical Medicine · 173d
Cleared Aug 21, 1985
DIAGNON MONOCOMBO VITAM. B12[57CO]/FOLATE[125I] RA
K851377 · CDD
Diagnon Corp.
Chemistry · 135d
Cleared Aug 21, 1985
VIBRECTOR
K851646 · LIL
Multicept, Aps.
Gastroenterology & Urology · 124d
Cleared Aug 21, 1985
CESIUM 137 SOURCE, CSM-4, CSM-11, CSM-41
K852023 · KXK
Syncor Intl. Corp.
Radiology · 105d
Cleared Aug 21, 1985
VERSA STIM 380, MUSCLE STIMULATOR
K852077 · IPF
Electro-Med Health Industries, Inc.
Physical Medicine · 100d
Cleared Aug 21, 1985
CHLORIDE REAGENT
K852169 · CHJ
Pointe Scientific, Inc.,
Chemistry · 93d
Cleared Aug 21, 1985
URETERAL DILATOR
K852324 · EZN
American Edwards Laboratories
Gastroenterology & Urology · 83d
Cleared Aug 21, 1985
IN VITRO TESTS FOR PHOSPHATASE & BLOOD NITROGEN
K852441 · CJE
Clinical Data, Inc.
Chemistry · 72d
Cleared Aug 21, 1985
RIONET HEARING AID HB-34HT
K852451 · ESD
Rion Acoustic Instruments, Inc.
Ear, Nose, Throat · 72d