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
100513–100536 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 13, 1995
SIDEKICK POWER WHEELCHAIR
K954044 · ITI
21st Century Scientific, Inc.
Physical Medicine · 45d
Cleared Oct 13, 1995
CUSTOMCARE SEATING SYSTEM
K954117 · KIC
Span-America Medical Systems, Inc.
Physical Medicine · 42d
Cleared Oct 13, 1995
LANDEEZ ALL-TERRAIN WHEELCHAIR
K954261 · IOR
Natural Access
Physical Medicine · 31d
Cleared Oct 13, 1995
STC DIAGNOSTICS AUTO-LYTE CREATININE ASSAY
K954266 · CGX
Solarcare Technologies Corp,Inc.
Chemistry · 31d
Cleared Oct 13, 1995
ENDOCARE MONOPOLAR ELECTRODES (MODIFICATION)
K954321 · GEI
Cytocare, Inc.
General & Plastic Surgery · 30d
Cleared Oct 13, 1995
RUSSON INDUSTRIES FURNITURE QUALITY WHEELCHAIR
K954344 · IOR
Russon Industries
Physical Medicine · 25d
Cleared Oct 13, 1995
CAMEO HOME PREGNANCY TEST
K954364 · LCX
Quidel Corp.
Chemistry · 25d
Cleared Oct 13, 1995
POLYKOTE POWDER FREE STERILE LATEX SURGEONS GLOVES
K954462 · KGO
Intl. Trade Management Co.
General Hospital · 18d
Cleared Oct 12, 1995
LOWER BOWEL EVACUATION SYSTEM
K941279 · KPL
Tiller Mind Body, Inc.
Gastroenterology & Urology · 575d
Cleared Oct 12, 1995
IOLAB.SITE CD PHACOEMULSIFICATION MODULE
K944993 · HQC
Chiron Vision Corp.
Ophthalmic · 365d
Cleared Oct 12, 1995
ACRYLIC DIPPED LATEX EXAMINATION GLOVES
K945506 · LYY
Ganz Industries Sdn. Bhd.
General Hospital · 337d
Cleared Oct 12, 1995
GASTROINTESTINAL TUBES & ACCESSORIES
K945618 · KNT
Applied Medical Technologies
Gastroenterology & Urology · 331d
Cleared Oct 12, 1995
VITALOGRAPH 2110 SOFTWARE INTERFACE
K950854 · DSH
Vitalograph , Ltd.
Cardiovascular · 227d
Cleared Oct 12, 1995
TRANSVENOUS, PERMANENT TINED TARGET TIP PACING LEADS
K951858 · DTB
Medtronic Vascular
Cardiovascular · 174d
Cleared Oct 12, 1995
OVAL SURGICAL FACE MASK
K951913 · FXX
Oval Industries, Ltd.
General Hospital · 171d
Cleared Oct 12, 1995
RXAIR 3000
K951981 · FRA
Clean Air Research & Development
General Hospital · 168d
Cleared Oct 12, 1995
POWDER-FREE LATEX EXAMINATION GLOVE
K952473 · LYY
M.M.R. Gloves Private , Ltd.
General Hospital · 139d
Cleared Oct 12, 1995
ROYAL SHIELD NON-STERILE LATEX EXAMINATION GLOVES
K952588 · LYY
Shield Gloves Manufacturer Sdn. Bhd....
General Hospital · 129d
Cleared Oct 12, 1995
VISITEC COLLAR BUTTON CATHETER {GRIFFITHS}
K953394 · LZU
Visitec Co.
Ophthalmic · 87d
Cleared Oct 12, 1995
MODEL 1207, HYDRODOT NEUROMONITORING SYSTEM ADHESIVE PADS
K953449 · GWQ
Physiometrix, Inc.
Neurology · 86d
Cleared Oct 12, 1995
BIPOLAR FORCEPS
K953479 · GEI
Megadyne Medical Products, Inc.
General & Plastic Surgery · 80d
Cleared Oct 12, 1995
NEUTRALON BROWN LATEX SURGICAL GLOVES
K953639 · KGO
Johnson & Johnson Medical, Inc.
General Hospital · 69d
Cleared Oct 12, 1995
INSTRUMENT SCOPE
K953685 · GWG
Clarus Medical Systems, Inc.
Neurology · 66d
Cleared Oct 12, 1995
DERRICK SURESHIELD
K953712 · KGO
M.P.S. Pharm'L Int'L
General Hospital · 64d