FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
129577–129600 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 26, 1989
CERAMIC FEMORAL HEAD
K893685 · LZO
Dow Corning Wright
Orthopedic · 133d
Cleared Sep 26, 1989
CN GLOVES
K893749 · LYY
C.N. Technocrats
General Hospital · 131d
Cleared Sep 26, 1989
OPUS MODEL 4001
K894065 · DXY
Ela Medical, Inc.
Cardiovascular · 110d
Cleared Sep 26, 1989
DERMAPORT VASCULAR ACCESS DEVICE MODEL NO. 50-1000
K894131 · DQY
Thermedics, Inc.
Cardiovascular · 105d
Cleared Sep 26, 1989
MEDIPART DISPOSABLE AEROSOL SYSTEM MP-070-PTD
K894138 · CAF
Medipart Jerry Alexander
Anesthesiology · 105d
Cleared Sep 26, 1989
IMX TOTAL B-HCG
K894182 · JHI
Abbott Laboratories
Chemistry · 102d
Cleared Sep 26, 1989
ST.JUDE MEDICAL PULSE 2100 CENTRIFUGAL PUMP
K894255 · KFM
St. Jude Medical, Inc.
Cardiovascular · 98d
Cleared Sep 26, 1989
M1400A TRANSMITTER,M1402 RECEIVER,M1401 MAINFRAME
K894277 · DXH
Hewlett-Packard Co.
Cardiovascular · 95d
Cleared Sep 26, 1989
FIRST IMPRESSION WITH CHLORHEXIDINE
K894281 · ELW
Coe Laboratories, Inc.
Dental · 95d
Cleared Sep 26, 1989
DMI PC HOLTER SCANNER
K894285 · DSI
Diagnostic Medical Instruments
Cardiovascular · 95d
Cleared Sep 26, 1989
DAIG PERCUTANEOUS CATHETER INTRO. & REMOVABLE HEMO
K894343 · DYB
Daig Corp.
Cardiovascular · 74d
Cleared Sep 26, 1989
LEONARDO INFORMATION SYSTEM
K894426 · CBK
Hamilton Medical, Inc.
Anesthesiology · 71d
Cleared Sep 26, 1989
PATIENT EXAMINATION GLOVES, LATEX
K894454 · LYY
Windwell Agencies Sdn. Bhd.
General Hospital · 96d
Cleared Sep 26, 1989
DANTEX VINYL EXAMINATION GLOVES
K894488 · LYZ
Dan Co., Ltd.
General Hospital · 70d
Cleared Sep 26, 1989
SYSMEX R-1000 AUTOMATED RETICULOCYTE ANALYZER
K894539 · GKL
Toa Medical Electronics USA, Inc.
Hematology · 68d
Cleared Sep 26, 1989
LATEX EXAMINATION GLOVES
K894616 · LYY
World Wide EX Im, Inc.
General Hospital · 68d
Cleared Sep 26, 1989
SURE-TEC LATEX EXAMINATION GLOVES
K894739 · LYY
All American Poly of Pennsylvania Corp.
General Hospital · 61d
Cleared Sep 26, 1989
PATIENT LATEX EXAMINATION GLOVES
K894758 · LYY
Agrimal Industries Sdn. Bhd.
General Hospital · 62d
Cleared Sep 26, 1989
LATEX PATIENT EXAMINATION GLOVE
K894796 · LYY
Bh Limela Industries Sdn. Bhd.
General Hospital · 60d
Cleared Sep 26, 1989
RAPIDEC UR
K894805 · JXA
Dms Products, Inc.
Microbiology · 60d
Cleared Sep 26, 1989
COMFEEL TRANSPARENT DRESSING
K894916 · KGX
Coloplast A/S
General & Plastic Surgery · 55d
Cleared Sep 26, 1989
SIDEWINDER 40CC DL INTRA-AORTIC BALLOON CATHETER
K894942 · DSP
Boston Scientific Corp
Cardiovascular · 54d
Cleared Sep 26, 1989
MEDPRIDE LATEX SURGEONS GLOVES
K895027 · KGO
Medpride
General Hospital · 49d
Cleared Sep 26, 1989
KUT-SHIELD
K895092 · FYH
Kut-Guard, Inc.
General Hospital · 43d