FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
84553–84576 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 05, 1999
SURGEON'S GLOVES PRE-POWDERED, MODELS 6.5, 7, 7.5, 8, 8.5
K992752 · KGO
Pt. Maja Agung Latexindo
General Hospital · 81d
Cleared Nov 05, 1999
SYNTHETIC POWDERED VINYL PATIENT EXAMINATION GLOVES
K992797 · LYZ
Shijiazhuang Hongxiang Plastics...
General Hospital · 78d
Cleared Nov 05, 1999
ANTIBACTERIAL ADHESIVE BANDAGE
K992817 · FRO
William Feinstein & Associates, Inc.
General & Plastic Surgery · 77d
Cleared Nov 05, 1999
QTEXX, NON-CHLORINATED, POWDER FREE NITRILE EXAMINATION GLOVES, POLYMER-COATED
K992924 · LZA
Latexx Partners Bhd.
General Hospital · 67d
Cleared Nov 05, 1999
DAISY PROTECTED SCALP VEIN SET
K992999 · FPA
Diasol, Inc.
General Hospital · 59d
Cleared Nov 05, 1999
MODIFICATION TO MP-3 POWER BASE CHAIR
K993032 · ITI
Merits Health Products., Inc.
Physical Medicine · 87d
Cleared Nov 05, 1999
SHELLY PROTECTED AV FISTULA NEEDLE
K993187 · FPA
Diasol, Inc.
General Hospital · 43d
Cleared Nov 05, 1999
INNOVATIVE GLOVES, LATEX EXAMINATION GLOVES, PREPOWDERED
K993221 · LYY
Innovative Gloves Co;, Ltd.
General Hospital · 39d
Cleared Nov 05, 1999
INNOVATIVE GLOVES, LATEX EXAMINATION GLOVES POWDERFREE
K993222 · LYY
Innovative Gloves Co;, Ltd.
General Hospital · 39d
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