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
130249–130272 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 14, 1989
ASPEN DISPOSABLE BIPOLAR CORD
K893732 · GEI
Conmedcorp
General & Plastic Surgery · 58d
Cleared Jul 14, 1989
VISTA MR 2055 HP SYSTEM AND 2055 UPGRADES
K893739 · LNH
Philips Medical Systems (Cleveland),...
Radiology · 58d
Cleared Jul 14, 1989
CEFIXIME, 5 MCG SENSI-DISC ANTIMIC SUSCEP TEST DIS
K893754 · JTN
Bd Becton Dickinson Vacutainer...
Microbiology · 56d
Cleared Jul 14, 1989
MODELS 1113 AND 1114 PACEMAKER LEADS
K893763 · DTB
Possis Medical, Inc.
Cardiovascular · 56d
Cleared Jul 14, 1989
PATIENT EXAMINATION GLOVES W/CORN STARCH POWDER
K893782 · LYY
Rubberex (M) Sdn Berhad
General Hospital · 53d
Cleared Jul 14, 1989
FLOOR STANDING, OPERATING AND EXAMINING LIGHT
K893813 · FSS
Astralite Corp.
General & Plastic Surgery · 52d
Cleared Jul 14, 1989
ADAMS BREAST IMPLANT PROTECTOR
K893870 · GCZ
Adept-Med Intl., Inc.
General & Plastic Surgery · 49d
Cleared Jul 14, 1989
QUANTITATIVE ASSAY FOR DET. OF IGG IGM ANTI-DSDNA
K893896 · LKJ
Biostar Medical Products, Inc.
Immunology · 45d
Cleared Jul 14, 1989
LATEX EXAMINATION GLOVES
K893901 · LYY
Tillotson Corp.
General Hospital · 45d
Cleared Jul 14, 1989
4 X 4 STERILE GAUZE SPONGE TRAY
K893902 · EFQ
Mumtaz I. Malik
General & Plastic Surgery · 45d
Cleared Jul 14, 1989
GOLD CLASS GRANDTEX/MULTIPLE(MFG:ZHUHAI GOLD CLASS
K893906 · LYY
Minette Sales Corp.
General Hospital · 60d
Cleared Jul 14, 1989
ISOLATION MASKS
K893939 · FXX
James River Corp.
General Hospital · 44d
Cleared Jul 14, 1989
PHARMACIA CAP SYSTEM IGE RIA AND FEIA
K893951 · DGC
Pharmacia, Inc.
Immunology · 43d
Cleared Jul 14, 1989
DECUBITUS CARE PAD
K893969 · FWZ
Gulftrade Exim, Inc.
General & Plastic Surgery · 42d
Cleared Jul 14, 1989
POWER PODIATRY CHAIR/TABLE #414, #416 & #417
K894017 · INQ
Midmark Corp.
Physical Medicine · 42d
Cleared Jul 14, 1989
MODIFIED LABELING OF SURGICAL GLOVES
K894034 · KGO
James River Corp.
General Hospital · 38d
Cleared Jul 14, 1989
QUIDEL TOTAL IGE TEST QUANTITATIVE VERSION
K894039 · DGO
Quidel Corp.
Immunology · 38d
Cleared Jul 14, 1989
IMPLANTABLE PACING LEADS W/IS-1 CONN., UNIPOLAR
K894040 · DTB
Medtronic Vascular
Cardiovascular · 38d
Cleared Jul 14, 1989
GOWN, OPERATING, SURGICAL
K894284 · FYA
Miroz Industries Co.
General Hospital · 21d
Cleared Jul 05, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K892955 · LYY
Awb Ent., Inc.
General Hospital · 84d
Cleared Jun 23, 1989
DELUXE CONTACT LENS HOLDER (HARD & SOFT) #283
K882384 · LRX
Magnivision, Inc.
Ophthalmic · 379d
Cleared Jun 23, 1989
NEWPORT VENTILATOR MODEL E150
K883809 · CBK
Newport Medical Instruments, Inc.
Anesthesiology · 288d
Cleared Jun 23, 1989
DPX BONE DENSITOMETER FOR TOTAL BODY BONE DENSITY
K884625 · KGI
Lunar
Radiology · 231d
Cleared Jun 23, 1989
THE GREAT WALL CONDOM
K884925 · HIS
Pacific Sales & Development Corp.
Obstetrics & Gynecology · 207d