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
72697–72720 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 17, 2003
CPC BY SORING GMBH
K030028 · GEI
Soring GmbH Medizintechnik
General & Plastic Surgery · 14d
Cleared Jan 17, 2003
VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG CONTROLS
K030067 · MJX
Ortho-Clinical Diagnostics
Microbiology · 10d
Cleared Jan 17, 2003
TRIAGE CARDIAC CALIBRATION VERIFICATION CONTROLS, TRIAGE CARDIO PROFILER...
K030088 · JJY
Biosite Incorporated
Chemistry · 7d
Cleared Jan 16, 2003
MAYBE?MOM MINI OVULATION MICROSCOPE
K013582 · CEP
Maybe?Mom
Chemistry · 443d
Cleared Jan 16, 2003
STRATUS CS D-DIMER (DDMR) METHOD (TESTPAK & DILPAK), MODELS CDDMR & CDDMR-D
K022976 · DAP
Dade Behring, Inc.
Hematology · 132d
Cleared Jan 16, 2003
MODIFICATION TO STANDARD HUMAN PLASMA
K023141 · JPA
Dade Behring, Inc.
Hematology · 118d
Cleared Jan 16, 2003
RDH-2000
K023213 · EIA
Anodia Systems
Dental · 112d
Cleared Jan 16, 2003
KLOCK WATCH STYLE DIGITAL BLOOD PRESSURE MONITOR
K023356 · DXQ
Card Guard Scientific Survival , Ltd.
Cardiovascular · 101d
Cleared Jan 16, 2003
DERMAGRIP-X POWDER FREE LATEX EXAMINATION GLOVES WITH SKIN-CARE INGREDIENTS...
K023490 · LYY
Wrp Asia Pacific Sdn. Bhd.
General Hospital · 92d
Cleared Jan 16, 2003
PRE-POWDERED LATEX SURGEON'S GLOVES
K023515 · KGO
Sanrea Healthcare Private Limited
General Hospital · 87d
Cleared Jan 16, 2003
RADIONICS VARILINK 2
K023519 · IYE
Radionics, A Division of Tyco...
Radiology · 87d
Cleared Jan 16, 2003
GENZYME CONTRAST II HCG URINE/SERUM TEST
K023544 · JHI
Genzyme Corp.
Chemistry · 86d
Cleared Jan 16, 2003
ENCLOSE ANASTOMOSIS ASSIST DEVICE
K023682 · DXC
Novare Surgical Systems, Inc.
Cardiovascular · 76d
Cleared Jan 16, 2003
TEMPORARY CEMENT-DC010002
K023727 · EMA
GC America, Inc.
Dental · 71d
Cleared Jan 16, 2003
SKINTACT
K023920 · DRX
Leonhard Lang GmbH
Cardiovascular · 52d
Cleared Jan 16, 2003
REPLACE ONE PIECE IMPLANT, HA, REPLACE ONE PIECE IMPLANT, TIUNITE
K023952 · DZE
Nobel Biocare Uas, Inc.
Dental · 50d
Cleared Jan 16, 2003
INNOVA 2000 AND INNOVA 2000S (MOBILE VERSION)
K024200 · OWB
Ge Medical Systems, Inc.
Radiology · 27d
Cleared Jan 16, 2003
SKINTACT ECG ELECTRODES WITH KL 02 LIQUID GEL
K024247 · DRX
Leonhard Lang GmbH
Cardiovascular · 24d
Cleared Jan 16, 2003
SKINTACT
K024264 · DRX
Leonhard Lang Co.
Cardiovascular · 24d
Cleared Jan 15, 2003
STEREOTAXIS NIOBE MAGNETIC NAVIGATION SYSTEM
K021555 · DXX
Stereotaxis, Inc.
Cardiovascular · 247d
Cleared Jan 15, 2003
OPTION NIV, MODEL 8414115, UPGRADE KIT NIV, MODEL 8414072
K023289 · CBK
Drager Medizintechnik GmbH
Anesthesiology · 105d
Cleared Jan 15, 2003
AURA 20 BIPOLAR ELECTROSURGICAL COAGULATOR, MODEL 26-2500
K023482 · GEI
Kirwan Surgical Products, Inc.
General & Plastic Surgery · 90d
Cleared Jan 15, 2003
NUAMPS
K023536 · OLT
Neuroscan
Neurology · 86d
Cleared Jan 15, 2003
RHEUMATOID FACTOR (RF)
K024067 · DHR
Abbott Laboratories
Immunology · 36d