FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
92593–92616 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 08, 1997
LOGIQ 1000 DIAGNOSTIC ULTRSOUND SYSTEM
K960527 · IYN
GE Medical Systems
Radiology · 580d
Cleared Sep 08, 1997
5 STAR MEDICAL ENDOSCOPE
K963354 · ODF
Five Star Medical, Inc.
Gastroenterology & Urology · 378d
Cleared Sep 08, 1997
AIRCAST VENA FLOW STERILE DISPOSABLE CUFFS
K964238 · JOW
Aircast, Inc.
Cardiovascular · 320d
Cleared Sep 08, 1997
BIOSURGICAL, CORP. MULTI CHAMBER SUCTION SYRINGE
K964597 · FMF
Biosurgical Corp.
General Hospital · 294d
Cleared Sep 08, 1997
CHASE THORACIC CATHETER
K971023 · DWF
Chase Medical, Inc.
Cardiovascular · 172d
Cleared Sep 08, 1997
DYE STOP AND SAVE - QUICKFILL
K971624 · FPA
Shepherd Laboratories, Inc.
General Hospital · 129d
Cleared Sep 08, 1997
STAPHYTECT PLUS/DRYSPOT STAPHYTECT PLUS
K972030 · JWX
Oxoid , Ltd.
Microbiology · 98d
Cleared Sep 08, 1997
DIGITIZER DIRECTOR (HSC025-01)
K972191 · LMD
Howtek, Inc.
Radiology · 90d
Cleared Sep 08, 1997
K 15 AUDIOMETER
K972221 · EWO
American Electromedics Corp.
Ear, Nose, Throat · 87d
Cleared Sep 08, 1997
LANTIS TREATSTATION
K972275 · IYE
Siemens Medical Solutions USA, Inc.
Radiology · 82d
Cleared Sep 08, 1997
CIMPAT N
K972485 · EMA
Arent, Fox, Kintner, Plotkin & Kahn
Dental · 68d
Cleared Sep 08, 1997
CEQUAL-QUANTITATIVE ANALYSIS FOR CARDIOLITE EXECUTING ON THE MEDASYS DIGITAL...
K972509 · KPS
Nuccardiac Software, Inc.
Radiology · 67d
Cleared Sep 08, 1997
GRASPING FORCEPS, RIGHT AND LEFT CURVED
K972519 · GEI
Richard Wolf Medical Instruments Corp.
General & Plastic Surgery · 63d
Cleared Sep 08, 1997
DRIED GRAM-POSITIVE MIC/COMBO PANELS
K972524 · JWY
Dade Intl., Inc.
Microbiology · 63d
Cleared Sep 08, 1997
MICROSCAN DRIED GRAM POSITIVE MIC/COMBO PANELS LEVOFLOXACIN
K972688 · JWY
Dade Microscan, Inc.
Microbiology · 63d
Cleared Sep 08, 1997
DRY & STORE
K972776 · ESD
Ear Technology Corp.
Ear, Nose, Throat · 45d
Cleared Sep 08, 1997
KARL STORZ CONTACT NASAL MICRO-ENDOSCOPES
K972855 · EOB
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 38d
Cleared Sep 05, 1997
FLEX-NECK PD CATHETER
K970159 · FJS
Janin Group, Inc.
Gastroenterology & Urology · 232d
Cleared Sep 05, 1997
P REFERENCE TPS (TREATMENT PLANNING SOFTWARE) 1.1
K970464 · IYE
Northwest Medical Physics Equipment,...
Radiology · 210d
Cleared Sep 05, 1997
KT AIR BED
K970468 · FNM
Kinetic Concepts, Inc.
General Hospital · 210d
Cleared Sep 05, 1997
MEDLITE IV Q-SWITCHED, FREQUENCY DOUBLED, ND:YAG LASER
K970808 · GEX
Continuum Biomedical, Inc.
General & Plastic Surgery · 184d
Cleared Sep 05, 1997
POWDER FREE SYNTHETIC EXAMINATION GLOVES
K971356 · LZA
Arista Latindo Industrial Ltd. P.T
General Hospital · 147d
Cleared Sep 05, 1997
AUTOMATIC ELECTRONIC HYSTEROSCOPIC INSUFFLATOR
K971492 · HIG
Bei Medical Systems Co., Inc.
Obstetrics & Gynecology · 134d
Cleared Sep 05, 1997
EZCHEK/HBA BLOOD COLLECTION KIT
K971919 · LCP
Flexsite Diagnostics, Inc.
Hematology · 105d