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
84049–84072 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 05, 1999
NITRILE POWDER FREE PATIENT EXAMINATION GLOVES
K993247 · LZA
Jda Intl., Inc.
General Hospital · 38d
Cleared Nov 05, 1999
COLDLIGHTSOURCE PL3000
K993300 · FCW
Fiber Imaging Technologies, Inc.
Gastroenterology & Urology · 35d
Cleared Nov 05, 1999
INNOVATIVE GLOVES, NITRILE BUTADIENE RUBBER POWDER-FREE
K993325 · LZA
Innovative Gloves Co;, Ltd.
General Hospital · 32d
Cleared Nov 05, 1999
GE LOGIQ 700 WITH CODED EXCITATION MODIFICATION
K993364 · IYO
Ge Medical Systems, Inc.
Radiology · 30d
Cleared Nov 05, 1999
GE LOGIQ 700 WITH HARMONIC IMAGING MODIFICATION
K993365 · IYO
Ge Medical Systems, Inc.
Radiology · 30d
Cleared Nov 05, 1999
ECHO SCAN, EASY SCAN
K993394 · IYO
Tomtec Imaging Systems GmbH
Radiology · 28d
Cleared Nov 05, 1999
ECHO VIEW, EASY VIEW, OMNI VIEW
K993398 · IYO
Tomtec Imaging Systems GmbH
Radiology · 28d
Cleared Nov 05, 1999
MODIFICATION TO BRENNEN BIOSYNTHETIC SURGICAL MESH MATRIX
K993459 · PAG
Advanced Uroscience, Inc.
Gastroenterology & Urology · 23d
Cleared Nov 04, 1999
BDPROBETEC ET CHLAMYDIA TRACHOMATIS AND NEISSERIA GONORRHOEAE AMPLIFIED DNA...
K984631 · LSL
Becton Dickinson Microbiology Systems
Microbiology · 309d
Cleared Nov 04, 1999
HPA PORTABLE KIDNEY PRESERVATION SYSTEM, MODEL J-1000-1
K990229 · KDN
Justec Medical Products, Inc.
Gastroenterology & Urology · 283d
Cleared Nov 04, 1999
PASCO MIC AND MIC/ID PANELS, CEFDINIR
K992853 · JTN
Pasco Laboratories, Inc.
Microbiology · 72d
Cleared Nov 04, 1999
BIO-RAD CODA NEONATAL GALT ASSAY
K993536 · KQP
Bio-Rad
Chemistry · 16d
Cleared Nov 03, 1999
AXON MP-1 MICROPOSITIONER
K990683 · HAW
Axon Instruments, Inc.
Neurology · 245d
Cleared Nov 03, 1999
BRAVO MULTI-MODALITY SYSTEM
K991054 · GWQ
Nicolet Biomedical, Inc.
Neurology · 218d
Cleared Nov 03, 1999
FACE-2-FACE CPR PROTECTION SHIELD
K991617 · CBP
Whiteline Plastics, Inc.
Anesthesiology · 177d
Cleared Nov 03, 1999
OLYMPUS NA-10J-KB ASPIRATION NEEDLE
K991672 · FCG
Olympus America, Inc.
Gastroenterology & Urology · 170d
Cleared Nov 03, 1999
DEVILBISS 5 LITER OXYGEN CONCENTRATOR
K991722 · CAW
Sunrise Medical Hhg, Inc.
Anesthesiology · 167d
Cleared Nov 03, 1999
SIEMENS FIO2 SENSOR
K991884 · CCL
Siemens Medical Solutions USA, Inc.
Anesthesiology · 154d
Cleared Nov 03, 1999
MUSE CARDIOVASCULAR INFORMATION SYSTEM
K992637 · DSI
General Electric Medical Systems...
Cardiovascular · 89d
Cleared Nov 03, 1999
PASCO MIC AND MIC/ID PANELS, QUINUPRISTIN/DALFOPRISTIN FOR NONFASTIDIOUS...
K992726 · JTN
Pasco Laboratories, Inc.
Microbiology · 82d
Cleared Nov 03, 1999
SYNERCID, 15 UG, BBL SENSI-DISC
K993186 · JTN
Bd Becton Dickinson Vacutainer...
Microbiology · 42d
Cleared Nov 03, 1999
NIKOPAD ELECTROSURGICAL GROUNDING PAD (*OR SOLD UNDER COMMERCIAL NAMES),...
K993306 · HAM
Paladin Medical, Inc.
General & Plastic Surgery · 30d
Cleared Nov 02, 1999
AD-TECH'S FORAMEN OVALE ELECTRODE
K990788 · GZL
Ad-Tech Medical Instrument Corp
Neurology · 237d
Cleared Nov 02, 1999
LM-70 (LIDOFILCON A) SPHERICAL AND TORIC SOFT CONTACT LENS FOR DAILY WEAR...
K991015 · LPL
Lamda Polytech , Ltd.
Ophthalmic · 221d