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
109465–109488 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 09, 1994
POWDER FREE LATEX EXAMINATION GLOVES
K933810 · LYY
Clydesdale Industries Sdn. Bhd.
General Hospital · 217d
Cleared Mar 09, 1994
PROFORM HA HIP SYSTEM
K934162 · JDO
Stelkast Company
Orthopedic · 194d
Cleared Mar 09, 1994
LIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER
K934174 · OCW
Ethicon, Inc.
General & Plastic Surgery · 194d
Cleared Mar 09, 1994
LASSO (SCHWAITZBERG) SUTURE SNARE
K934737 · GCJ
Performance Surgical Instruments Corp.
General & Plastic Surgery · 159d
Cleared Mar 09, 1994
TECNOL SPLASHGUARD
K934842 · LYU
Tecnol Medical Products, Inc.
General Hospital · 152d
Cleared Mar 09, 1994
S-ROM TOTAL HIP REPLACEMENT SYSTEM
K935078 · JDG
Joint Medical Products Corp.
Orthopedic · 135d
Cleared Mar 09, 1994
PATIENT EXAMINATION GLOVES
K935256 · LYY
Comfort Rubber Gloves Industries Sdn....
General Hospital · 128d
Cleared Mar 09, 1994
FX-CABLELOK(TM) STOP(TROCHANTER HOOK) SYSTEM
K935646 · JDQ
Biodynamic Technologies, Inc.
Orthopedic · 106d
Cleared Mar 09, 1994
FX-CABLELOK CABLE/PLATE SYSTEM
K935950 · JDQ
Buckman Co., Inc.
Orthopedic · 86d
Cleared Mar 09, 1994
STERILE GAUZE SPONGES
K936216 · EFQ
Dav-Mar Medical Products, Inc.
General & Plastic Surgery · 70d
Cleared Mar 09, 1994
CABOT MEDICAL NIAGRA-TRS THERMAL RETENTION SYSTEM
K940171 · DWJ
Cabot Medical Corp.
Cardiovascular · 57d
Cleared Mar 09, 1994
SE-CHECK
K940181 · JPK
Streck Laboratories, Inc.
Hematology · 56d
Cleared Mar 09, 1994
DUKAL NON-WOVEN GAUZE
K940440 · EFQ
Dukal Corp.
General & Plastic Surgery · 37d
Cleared Mar 07, 1994
MICROSENSOR INTRACRANIAL PRESSURE TRANSDUCER
K914479 · GWM
Codman & Shurtleff, Inc.
Neurology · 881d
Cleared Mar 07, 1994
BARD 500ML RESERVOIR HOLDER
K915649 · FRN
C.R. Bard, Inc.
General Hospital · 810d
Cleared Mar 07, 1994
EPISENSOR PLUS
K920740 · CAR
Industrias Palex C/O Dma Med-Chem Corp.
General Hospital · 747d
Cleared Mar 07, 1994
DW246 #43
K926177 · EJT
Ivoclar North America, Inc.
Dental · 454d
Cleared Mar 07, 1994
ANGIOCOR SIDEHOLE INFUSION CATHETER
K926293 · LJS
Angiocor
General Hospital · 448d
Cleared Mar 07, 1994
3.0 FR GROSHONG PERIPHER INSERT CENT VENOUS CATH
K926331 · LJS
Bard Access Systems, Inc.
General Hospital · 446d
Cleared Mar 07, 1994
MAST CLA ALLERGY SYSTEM
K926420 · DHB
Mast Immunosystems
Immunology · 439d
Cleared Mar 07, 1994
AMNIPERF(TM)
K926425 · HGE
Raymart Development Co.
Obstetrics & Gynecology · 439d
Cleared Mar 07, 1994
BAUMER STAPLES
K930967 · JDR
Baumer Ortopedia , Ltd.
Orthopedic · 376d
Cleared Mar 07, 1994
SAFELINE SYSTEM IV ADMINISTRATION SETS & COMPONENT
K931377 · FPA
Mcgaw, Inc.
General Hospital · 354d
Cleared Mar 07, 1994
CORFAX CARDIAC DATA TRANSMITTER
K931585 · DXH
Ralin Medical, Inc.
Cardiovascular · 341d