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
109057–109080 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 29, 1994
CIDEX ACTIVATED DIALDEHYDE SOLUTION
K924434 · LRJ
Johnson & Johnson Medical, Inc.
General Hospital · 574d
Cleared Mar 29, 1994
VIVUS 5000 INFUSION SYSTEM
K924527 · FRN
I-Flow Corp.
General Hospital · 567d
Cleared Mar 29, 1994
M100 POWERED WHEELCHAIR
K925724 · ITI
Mcnally Industries, Inc.
Physical Medicine · 501d
Cleared Mar 29, 1994
FUJINON VIDEO LAPAROSCOPE, MODIFIED
K930297 · FWF
Fujinon, Inc.
General & Plastic Surgery · 432d
Cleared Mar 29, 1994
BAUMER PINS
K930969 · HTY
Baumer Ortopedia , Ltd.
Orthopedic · 398d
Cleared Mar 29, 1994
INTRAMEDULLARY SYSTEMS
K930972 · HSB
Baumer Ortopedia , Ltd.
Orthopedic · 398d
Cleared Mar 29, 1994
NUCLEOTOME E KIT
K931109 · HRX
Surgical Dynamics, Inc.
Orthopedic · 391d
Cleared Mar 29, 1994
TECHMEDICA CONTINUUM HIP SYSTEM
K931929 · LZO
Techmedica, Inc.
Orthopedic · 347d
Cleared Mar 29, 1994
KAPPLER PRO/VENT PROCEDURE GOWN
K932694 · FYA
Kappler, Inc.
General Hospital · 299d
Cleared Mar 29, 1994
CEDARS-SINAI QUANTITIVE THALLIUM 201 ANALYSIS
K932701 · IYX
Nuccardiac Software, Inc.
Radiology · 299d
Cleared Mar 29, 1994
KAPPLER PRO/VENT BOOT
K932738 · FXP
Kappler, Inc.
General Hospital · 295d
Cleared Mar 29, 1994
HYDRASPUN M STERILIZATION WRAP
K933550 · FRG
Ahlstrom Dexter
General Hospital · 251d
Cleared Mar 29, 1994
A549 CULTURE CELL
K933923 · KIR
Neogenex
Pathology · 231d
Cleared Mar 29, 1994
MCCOY CULTURE CELL
K933924 · KIR
Neogenex
Pathology · 231d
Cleared Mar 29, 1994
MRC-5 CULTURE CELL
K933925 · KIR
Neogenex
Pathology · 231d
Cleared Mar 29, 1994
LLCMK2 CULTURE CELLS
K933926 · KIR
Neogenex
Pathology · 231d
Cleared Mar 29, 1994
COMMUTER (MANUAL/POWER WHEELCLHAIR)
K934232 · ITI
Fortress Lite-Style Wheelchairs, Inc.
Physical Medicine · 222d
Cleared Mar 29, 1994
UNIVERSAL CONTROLLER, MODEL 100
K934543 · LDR
Metamed, Inc.
General Hospital · 194d
Cleared Mar 29, 1994
SENSI-CAL AMCO AEPA-1
K935566 · LIE
Radiometer America, Inc.
Microbiology · 131d
Cleared Mar 29, 1994
CP BODY ARRAY/ CP SPINE ARRAY COIL
K935627 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 125d
Cleared Mar 29, 1994
CP FLEXIBLE COILS/ LP CIRCULAR FLEX COILS
K935752 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 123d
Cleared Mar 29, 1994
MEDTRONIC INTERVENTIONAL VASCULAR Y-ADAPTER, TRI-ADAPTER, TRI-ADAPTER &...
K940063 · LIT
Medtronics Interventional Vascular
Cardiovascular · 82d
Cleared Mar 29, 1994
MAGELLAN
K940300 · KPS
GE Medical Systems
Radiology · 64d
Cleared Mar 29, 1994
FLEX-I-PORT
K940587 · GCJ
Access Surgical Intl., Inc.
General & Plastic Surgery · 49d