FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
130849–130872 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Jun 23, 1989
BE #1100 MOISTURE TRAP & BE #1102/50 DISP CANISTER
K884927 · CAN
Instrumentation Industries, Inc.
Anesthesiology · 207d
Cleared Jun 23, 1989
BIO-MATE(TM) EPIDURAL CATHETER
K884969 · BSO
Medevice, Inc.
Anesthesiology · 205d
Cleared Jun 23, 1989
COI 72 HR COLLAGEN SHIELD
K885015 · MOE
Chiron Ophthalmics
Ophthalmic · 200d
Cleared Jun 23, 1989
THROMBOSTIN IFA*
K885107 · GJS
Investigacion Farmaceutica S.A. DE C.V.
Hematology · 193d
Cleared Jun 23, 1989
IMD 7GX
K885115 · EFB
Medical Dental Technology Co.
Dental · 193d
Cleared Jun 23, 1989
IMX RUBELLA IGM, MICROPART. ENZYME IMMUNOASSAY
K885295 · LFX
Abbott Laboratories
Microbiology · 178d
Cleared Jun 23, 1989
IMX RUBELLA IGG, MICROPARTICLE ENZYME IMMUNOASSAY
K885297 · LFX
Abbott Laboratories
Microbiology · 178d
Cleared Jun 23, 1989
IMX TOXO IGG ANTIBODY ASSAY
K890031 · LGD
Abbott Laboratories
Microbiology · 170d
Cleared Jun 23, 1989
IMX TOXO IGM ANTIBODY ASSAY
K890032 · LGD
Abbott Laboratories
Microbiology · 170d
Cleared Jun 23, 1989
HI STANDARD MAGNETIC RESONANCE DIAGNOSTIC DEVICE
K890092 · LNH
Health Images, Inc.
Radiology · 164d