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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
130393–130416 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 22, 1989
SINGLE USE VINYL EXAM GLOVES - COLOR CODED
K892976 · LYZ
Phoenix Medical Technology, Inc.
General Hospital · 71d
Cleared Jun 22, 1989
HPI NON STERILE EXAM GLOVES
K893018 · LYY
Tillotson Corp.
General Hospital · 71d
Cleared Jun 22, 1989
GENT-L-KARE STER SUCT CATH TRAY W/14 FR/STER WATER
K893135 · JOL
Premium Plastics, Inc.
General Hospital · 58d
Cleared Jun 22, 1989
PROTHROMBIN TIME (PT) BY HEMOCHRON
K893378 · GJS
International Technidyne Corp.
Hematology · 52d
Cleared Jun 22, 1989
DESERET PRN ADAPTER
K893406 · KGZ
Deseret Medical, Inc.
General & Plastic Surgery · 51d
Cleared Jun 22, 1989
SURGIFRESH SUB-MICRON MASK NO. 901008-000
K893417 · FXX
Texas Medical Products, Inc.
General Hospital · 51d
Cleared Jun 22, 1989
EXTRA STRENGTH EFFERGRIP DENTURE ADHESIVE CREAM
K893452 · IZZ
Warner-Lambert Co.
Radiology · 50d
Cleared Jun 22, 1989
FIBEROPTIC HEADLIGHT SYSTEM
K893458 · EBA
Cuda Products Co.
Dental · 51d
Cleared Jun 22, 1989
MODEL M2-150/I-150/M2-150T/M3-150/M2-150,300-300
K893491 · FST
Cuda Products Co.
General & Plastic Surgery · 49d
Cleared Jun 22, 1989
CUFF SPECULUM
K893531 · KPL
Mountain Medical Equipment, Inc.
Gastroenterology & Urology · 45d
Cleared Jun 22, 1989
AEROMAT MRS-1000
K893614 · IOQ
Integrated Therapy Products, Inc.
Physical Medicine · 43d
Cleared Jun 22, 1989
COLD/HOT FLUID RADIATION PAD NEUTECH
K893706 · ILO
Burke, Inc.
Physical Medicine · 35d
Cleared Jun 22, 1989
FLUIDIZED AIR BED
K893708 · IOQ
Gsi Development Co.
Physical Medicine · 35d
Cleared Jun 22, 1989
TISSUE EMBEDDING MEDIUM
K893772 · KEO
Stephens Scientific
Pathology · 31d
Cleared Jun 21, 1989
MP TEST
K882596 · LJZ
Diatech Diagnostica , Ltd.
Microbiology · 362d
Cleared Jun 21, 1989
PHARMA-PLAST INSULIN INFUSION SET
K884978 · LZG
Pharma-Plast USA, Inc.
General Hospital · 203d
Cleared Jun 21, 1989
SANITARY NAPKIN PADS
K890125 · HHD
Landen Corp.
Obstetrics & Gynecology · 162d
Cleared Jun 21, 1989
HANDTYMP SCREENER MODEL 2000 + 2002 REMOTE TRANS.
K890864 · ETY
Rastronics USA, Inc.
Ear, Nose, Throat · 120d
Cleared Jun 21, 1989
PATIENT EXAMINATION GLOVES
K890930 · LYY
Thaima Products Co., Ltd.
General Hospital · 117d
Cleared Jun 21, 1989
ACS COLLOID OSMOTIC PRESSURE CALIBRATOR
K892213 · JIW
Analytical Control Systems, Inc.
Chemistry · 79d
Cleared Jun 21, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K892309 · LYY
Min an Chemical Industrial Co., Ltd.
General Hospital · 76d
Cleared Jun 21, 1989
PATIENT EXAMINATION GLOVES
K892480 · LYY
Foodhandler, Inc.
General Hospital · 75d
Cleared Jun 21, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K892506 · LYY
Universal Latex Products Co., Ltd.
General Hospital · 69d
Cleared Jun 21, 1989
CANNULATED BIOPSY FORCEPS
K892687 · EOQ
Zinnanti Surgical Instruments, Inc.
Ear, Nose, Throat · 69d