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
82201–82224 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 01, 2000
BONE BIOPSY NEEDLE
K001132 · KNW
Promex, Inc.
Gastroenterology & Urology · 21d
Cleared Apr 28, 2000
DERMAPIK II SKIN TEST SYSTEM, DERMAPIK II (SINGLE TEST DEVICE), POLYPIK II...
K000299 · SCL
Biomedex, Inc.
General Hospital · 88d
Cleared Apr 28, 2000
EZ CONNECT RESIN
K000357 · EBF
Kerr Dental Materials Center
Dental · 84d
Cleared Apr 28, 2000
OPTI-FREE EXPRESS LENS DROPS
K000385 · MRC
Alcon Universal, Ltd.
Ophthalmic · 81d
Cleared Apr 28, 2000
DIXI 2
K000428 · EHD
Planmeca Oy
Radiology · 79d
Cleared Apr 28, 2000
MEDTRONIC MODEL 7499 EXTENSION
K000445 · GZB
Medtronic Vascular
Neurology · 78d
Cleared Apr 28, 2000
SILK NONABSORBABLE SURGICAL SUTURES, USP
K000541 · GAP
Arc Medical Supplies (Beijing) Co, Ltd.
General & Plastic Surgery · 71d
Cleared Apr 28, 2000
PLAIN AND CHRONIC GUT ABSORBABLE SURGICAL SUTURES, USP
K000542 · GAL
Arc Medical Supplies (Beijing) Co, Ltd.
General & Plastic Surgery · 71d
Cleared Apr 28, 2000
POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABEL CLAIM CONTAINS 50...
K000667 · LYY
Protection Gloves Sdn. Bhd.
General Hospital · 60d
Cleared Apr 28, 2000
POWDER-FREE NON-VHLORINATED POLYMER COATED LATEX EXAMINATION GLOVES CONTAINS...
K000668 · LYY
Protection Gloves Sdn. Bhd.
General Hospital · 60d
Cleared Apr 28, 2000
SMALL FRAGMENT DYNAMIC COMPRESSION LOCKING (DCL) SYSTEM
K000684 · KTT
Synthes (Usa)
Orthopedic · 59d
Cleared Apr 28, 2000
UNIGLOVE NITRILE POWDER-FREE EXAMINATION GLOVES
K000689 · LZA
N.S. Uni-Gloves Sdn. Bhd.
General Hospital · 59d
Cleared Apr 28, 2000
STERILE LATEX POWDERED PATIENT EXAMINATION GLOVES
K000891 · LYY
Fitco Dipped Products Pvt., Ltd.
General Hospital · 39d
Cleared Apr 28, 2000
KERR GEL ETCHANT
K000954 · KLE
Sybron Dental Specialties, Inc.
Dental · 35d
Cleared Apr 28, 2000
8100 VITAL SIGNS MONITOR
K001020 · MWI
Criticare Systems, Inc.
Cardiovascular · 29d
Cleared Apr 28, 2000
GUTHRIE LATEX SURGICAL GLOVE (PRE-POWDERED)
K001047 · KGO
Guthrie Medicare Products (Melaka)...
General Hospital · 28d
Cleared Apr 28, 2000
RX EVEREST
K001051 · EJT
Jeneric/Pentron, Inc.
Dental · 25d
Cleared Apr 28, 2000
SAFE TOUCH NATURAL RUBBER POWDERED LATEX EXAMINATION GLOVES
K001094 · LYY
Jb Star Sdn Bhd
General Hospital · 24d
Cleared Apr 28, 2000
CORDIS INTRODUCER GUIDE
K001136 · DQY
Cordis Corp.
Cardiovascular · 18d
Cleared Apr 28, 2000
POWDER-FREE LATEX EXAMINATION GLOVE STERILE WITH OPTIONAL PROTEIN LABELING...
K001216 · LYY
Fitco Dipped Products Pvt., Ltd.
General Hospital · 14d
Cleared Apr 28, 2000
GYRUS ENDOUROLOGY SYSTEM: AXIPOLAR RESECTOSCOPE LOOP ELECTRODE
K001270 · FJL
Gyrus Medical , Ltd.
Gastroenterology & Urology · 8d
Cleared Apr 28, 2000
GT990402 DIGITAL THERMOMETER
K001279 · FLL
Global Treasure , Ltd.
General Hospital · 7d
Cleared Apr 28, 2000
PERITONEAL DIALYSIS CATHETERS AND ADAPTERS
K993149 · FJS
Medionics International, Inc.
Gastroenterology & Urology · 220d
Cleared Apr 28, 2000
POSSIS ANGIOJET X-STREAM RHEOLYTIC THROMBECTOMY CATHETER, MODEL 103587-002
K993564 · MCW
Possis Medical, Inc.
Cardiovascular · 190d