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
82705–82728 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 02, 2000
SHELHIGH NO-REACT DURA SHIELD
K982101 · GXQ
Shelhigh, Inc.
Neurology · 687d
Cleared May 02, 2000
CEDIA DAU AMPHASSURE ASSAY
K994380 · DKZ
Microgenics Corp.
Toxicology · 127d
Cleared May 01, 2000
BIO-FASTAK SUTURE ANCHOR, MODEL AR-1324B
K000506 · MAI
Arthrex, Inc.
Orthopedic · 76d
Cleared May 01, 2000
MACROPRO GEL
K000518 · MGQ
Brennen Medical, Inc.
General & Plastic Surgery · 75d
Cleared May 01, 2000
GLUCANPRO
K000519 · MGQ
Brennen Medical, Inc.
General & Plastic Surgery · 75d
Cleared May 01, 2000
SYNTHES LARGE FRAGMENT DYNAMIC COMPRESSION LOCKING (DCL) SYSTEM
K000682 · KTT
Synthes (Usa)
Orthopedic · 62d
Cleared May 01, 2000
A100 AESTHETIC DIODE LASER
K000982 · GEX
Diomed, Inc.
General & Plastic Surgery · 35d
Cleared May 01, 2000
RECUMBENT BATHING SYSTEMS, RHAPSODY AND PRIMO
K001079 · ILJ
Arjo, Inc.
Physical Medicine · 27d
Cleared May 01, 2000
MODIFICATION TO ONYX, FINGER CLIP PULSE OXIMETER, MODEL 9500
K001085 · DQA
Nonin Medical, Inc.
Anesthesiology · 27d
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