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
105649–105672 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 21, 1994
MICRO MPM
K940375 · CAP
Micro Direct, Inc.
Anesthesiology · 299d
Cleared Nov 21, 1994
INSIGHT ELECTRONIC ALIGNMENT INDICATOR
K940812 · KQX
Andronic Devices, Ltd.
Neurology · 272d
Cleared Nov 21, 1994
IMPAC TORQUE WRENCH
K940998 · DZE
Vident
Dental · 262d
Cleared Nov 21, 1994
VIDENT IMPAC INFINITE POSITION ABUTMENT
K941247 · DZE
Vident
Dental · 251d
Cleared Nov 21, 1994
SPECIALTY ASSAYED CONTROL-2 CAT. NO. 5302
K941872 · GGC
Helena Laboratories
Hematology · 217d
Cleared Nov 21, 1994
9100 MUTIGAS MONITOR
K941971 · CCK
Bci Intl., Inc.
Anesthesiology · 213d
Cleared Nov 21, 1994
CREATINE KINASE MB DETERMINATION (UV)
K942958 · JHW
Biochemical Trade, Inc.
Chemistry · 151d
Cleared Nov 21, 1994
MONOCLONAL MOUSE ANTI-HUMAN B-CELL
K943284 · GKZ
Dako Corp.
Hematology · 137d
Cleared Nov 21, 1994
DANEKSCOPE OPTI-PROBE
K943676 · HRX
Danek Medical, Inc.
Orthopedic · 118d
Cleared Nov 21, 1994
STERILE WATER FOR IRRIGATION
K943828 · JOL
Orion Life Systems, Inc.
General Hospital · 108d
Cleared Nov 21, 1994
PRE-FILLED SYSRINGE W/STERILE WATER
K943829 · JOL
Orion Life Systems, Inc.
General Hospital · 108d
Cleared Nov 21, 1994
PRE-FILLED SYRINGE W/STERILE 0.9% SODIUM CHLORIDE SOLUTION
K943830 · JOL
Orion Life Systems, Inc.
General Hospital · 108d
Cleared Nov 21, 1994
PRE-FILLED 30CC INFLATION SYRINGE W/STERILE WATER
K943831 · JOL
Orion Life Systems, Inc.
General Hospital · 108d
Cleared Nov 21, 1994
STERILE .9% SODIUM CHLORIDE FOR IRRATION
K943832 · JOL
Orion Life Systems, Inc.
General Hospital · 108d
Cleared Nov 21, 1994
STERILE .9% SODIUM CHLORIDE SOLUTION
K943834 · JOL
Orion Life Systems, Inc.
General Hospital · 108d
Cleared Nov 21, 1994
PRE-FILLED 10CC INFLATION SYRINGE W/STERILE WATER
K943836 · JOL
Orion Life Systems, Inc.
General Hospital · 108d
Cleared Nov 21, 1994
CX(TM) BENZODIAZEPINE(BENZ) REAGENT FOR SYCHRON CX SYS
K944076 · JXM
Beckman Instruments, Inc.
Toxicology · 139d
Cleared Nov 21, 1994
CX(TM) CANNABINOID 100 NG(THC) REAGENT/SYNCHRON CX SYS
K944088 · LDJ
Beckman Instruments, Inc.
Toxicology · 139d
Cleared Nov 21, 1994
HEP-2000 FLUORESCENT ANA-RO TEST SYSTEM
K944096 · DHN
Immuno Concepts, Inc.
Microbiology · 91d
Cleared Nov 21, 1994
MONOCLONAL MOUSE ANTI-HUMAN T-CELL, CD8, RPE-CONJUGATED, CLONE DK25
K944253 · GKZ
Dako Corp.
Hematology · 82d
Cleared Nov 21, 1994
DIASTAT ENA SINGLE WELL SCREEN KIT
K944505 · LLL
Shield Diagnostics, Ltd.
Immunology · 68d
Cleared Nov 21, 1994
CALIBRATORS
K944701 · JIS
Diagnostic Reagents, Inc.
Chemistry · 59d
Cleared Nov 21, 1994
ACCESS CK-MB REAGENTS
K945083 · JHS
Bio-Rad Laboratories, Inc.
Chemistry · 35d
Cleared Nov 18, 1994
FLEXIBLE HYDROXYLAPATITE/SILICONE SOFT CHIN IMPLAN
K925610 · FWP
Microtek Medical, Inc.
General & Plastic Surgery · 743d