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
141841–141864 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 03, 1986
E-VAC(TM)
K862875 · BTA
Laerdal California, Inc.
General & Plastic Surgery · 96d
Cleared Nov 03, 1986
MIDDLE EAR ANALYZER (IMPEDANCE AUDIOMETER)
K863353 · ETY
Grason-Stadler, Inc.
Ear, Nose, Throat · 66d
Cleared Nov 03, 1986
SR-IVOLEN TRAY MATERIAL
K863421 · EBH
Ivoclar USA, Inc.
Dental · 60d
Cleared Nov 03, 1986
UPDATED STERILE ENDOTRACHEAL BRUSHES
K863635 · EPE
Biological & Environmental Control...
Anesthesiology · 47d
Cleared Nov 03, 1986
CALIBRATION GAS FOR SERVO GAS MONITOR 120
K863675 · BXK
Siemens Elema AB
Anesthesiology · 45d
Cleared Nov 03, 1986
MODEL 493-08 POLYFLEX ENDOCARDIAL LEAD
K863781 · DTB
Intermedics, Inc.
Cardiovascular · 38d
Cleared Nov 03, 1986
TANDEM-M IMMUNOENZYMETRIC ASSAY FOR IGE--
K863858 · DGC
Hybritech, Inc.
Immunology · 31d
Cleared Nov 03, 1986
MODEL 366-28 ADAPTAID(TM) STEP-DOWN ADAPTER
K864047 · DTB
Intermedics, Inc.
Cardiovascular · 18d
Cleared Nov 03, 1986
MODEL 366-27 ADAPTAID(TM) STEP-DOWN ADAPTER
K864048 · DTB
Intermedics, Inc.
Cardiovascular · 17d
Cleared Nov 03, 1986
HITACHI HAND HELD MASSAGER A/C POWERED
K864088 · ISA
Hitachi Sales Corporation of America
Physical Medicine · 13d
Cleared Nov 03, 1986
SUPPORT ARM
K864117
Leonard Medical, Inc.
Neurology · 13d
Cleared Nov 03, 1986
CORDIS CONTRAST INJECTION LINES
K864141 · DQO
Cordis Corp.
Cardiovascular · 12d
Cleared Nov 03, 1986
DEGUPAL
K864162 · EJS
Degussa Dental, Inc.
Dental · 11d
Cleared Nov 03, 1986
SOMATICS MOUTH GUARD (BITE BLOCK)
K864181 · JXL
Somatics, Inc.
Neurology · 7d
Cleared Oct 31, 1986
LUER LOCK SKIRT
K862451 · DTL
Hewlett-Packard Co.
Cardiovascular · 126d
Cleared Oct 31, 1986
TDMAC-HEPARIN COATED RMI CAROTID BY-PASS SHUNT
K862634 · DWF
Research Medical, Inc.
Cardiovascular · 113d
Cleared Oct 31, 1986
QUINTON Q.CATH
K862740 · DQK
Quinton, Inc.
Cardiovascular · 102d
Cleared Oct 31, 1986
NEPHROSTOMY SET
K862742 · LJE
Meadox Surgimed, Inc.
Gastroenterology & Urology · 102d
Cleared Oct 31, 1986
BI-PLANE TRANSRECTAL PROBE NUMBER H4221T
K862911 · ITX
General Electric Co.
Radiology · 91d
Cleared Oct 31, 1986
HATCHER STONE EXTRACTOR - DISPOSABLE CATHETER
K862949 · LQR
Oscor Medical Corp.
Gastroenterology & Urology · 87d
Cleared Oct 31, 1986
3.2MM UNIPOLAR & BIPOLAR LEAD CONNECTORS (VS-1)
K862966 · DTB
Oscor Medical Corp.
Cardiovascular · 86d
Cleared Oct 31, 1986
DISPOSABLE INTRAVENOUS HYPERALIMENTATION BAGS
K863040 · KPE
Cher Mel Corp.
General Hospital · 80d
Cleared Oct 31, 1986
MIRALITE
K863246 · HQF
Mira, Inc.
Ophthalmic · 70d
Cleared Oct 31, 1986
CARE + PLUS IRREGATION TRAY
K863281 · KOD
Welmed Systems, Inc.
Gastroenterology & Urology · 67d