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
110137–110160 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 04, 1994
EPISEAL ADHESIVE WOUND CLOSURE STRIPS
K935725 · KGX
Deroyal Industries, Inc.
General & Plastic Surgery · 65d
Cleared Feb 04, 1994
MITRAFLEX CAVITY WOUND DRESSING
K935783 · KMF
Polymedica Industries, Inc.
General & Plastic Surgery · 60d
Cleared Feb 04, 1994
CHALLENGE POWDER-FREE, HYPOALLERGENIC, SYNTHETIC SURGICAL GLOVES
K935917 · KGB
Bd Becton Dickinson Vacutainer...
Anesthesiology · 56d
Cleared Feb 04, 1994
SARNS AIR DETECTION SYSTEM
K935977 · KRL
3M Health Care, Sarns
Cardiovascular · 53d
Cleared Feb 04, 1994
DAVINCI RECONFIGURABLE LAPAROSCOPIC SURGICAL INSTRUMENTS
K935999 · GCJ
Da Vinci Medical, Inc.
General & Plastic Surgery · 51d
Cleared Feb 04, 1994
NON-CORNING (HUBER) NEEDLE
K936029 · FMI
Therex Corp.
General Hospital · 49d
Cleared Feb 04, 1994
TREND SET 2 PLUS
K936070 · ELW
Confi-Dental Products Co.
Dental · 46d
Cleared Feb 04, 1994
LAPAROSCOPIC TROCAR STARTER SCALPEL
K936154 · GCJ
Bd Becton Dickinson Vacutainer...
General & Plastic Surgery · 39d
Cleared Feb 04, 1994
BISCO COMPOSITE
K940030 · EMA
Bisco, Inc.
Dental · 32d
Cleared Feb 03, 1994
DECONTAMINATING MACHINES, LS-850, LS-76, DW/T-216, T-21
K911120 · MEC
Hamo USA, Inc.
General Hospital · 1060d
Cleared Feb 03, 1994
HA-BIONTEGRATED DENTAL IMPLANT SYSTEMS
K914137 · DZE
Lifecore Biomedical, Inc.
Dental · 871d
Cleared Feb 03, 1994
SPERM MAINTENANCE MEDIUM WITH GLYCEROL
K914541 · MFD
Irvine Scientific
Obstetrics & Gynecology · 846d
Cleared Feb 03, 1994
ULTRAFLOW SUCTION-IRRIGATION CANNULA
K921335 · HET
Endoscopic Surgical Products, Inc.
Obstetrics & Gynecology · 687d
Cleared Feb 03, 1994
LATEX PATIENT EXAMINATION GLOVES
K924356 · LYY
Medi Pure Corp.
General Hospital · 527d
Cleared Feb 03, 1994
LATEX PATIENT EXAMINATION GLOVES
K924357 · LYY
Asia Pacific Latex Sdn Bhd
General Hospital · 527d
Cleared Feb 03, 1994
ISOLAIR 2 FLUID RESIST SURG/PROCE/CONE/EARLOOP MAS
K925185 · FXX
Louis M. Gerson Co., Inc.
General Hospital · 477d
Cleared Feb 03, 1994
DISPOSABLE UNIVERSAL LAPORASCOPIC SCISSORS
K925850 · GEI
H.S. Intl. Co., Inc.
General & Plastic Surgery · 442d
Cleared Feb 03, 1994
BRASS NICK IMPRES TRAY/AMALGAM CAR/SYRIN CART/ARTI
K926121 · EJI
Dentmed , Ltd.
Dental · 427d
Cleared Feb 03, 1994
.9% NORMAL SALINE TUBE/STERILE WATER TUBE
K926405 · FOZ
Gam-Med Packaging Corp.
General Hospital · 409d
Cleared Feb 03, 1994
BIOPSY CUP FORCEPS
K930180 · GCJ
Surgical Technologies, Inc.
General & Plastic Surgery · 385d
Cleared Feb 03, 1994
MEDIGLOVES, MEDPAC, BOSTON, FISHERBRAND, GLOVES
K930794 · KGO
Medigloves , Ltd.
General Hospital · 352d
Cleared Feb 03, 1994
MEDIGLOVES, FISHERBRAND, MEDIPRODUCTS GLOVES
K930795 · LYY
Medigloves , Ltd.
General Hospital · 352d
Cleared Feb 03, 1994
DISPOSABLE AMA STERILE DRAPE SHEET, CAT. NO. 5252
K931091 · KKX
Alliance Medical, Inc.
General Hospital · 337d
Cleared Feb 03, 1994
FAST'N'FLAMMATORY KIT
K931241 · GIA
Techlab, Inc.
Hematology · 329d