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
158473–158496 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 17, 1982
DIA SCOPE
K822087 · KNT
Exitec, Inc.
Gastroenterology & Urology · 127d
Cleared Nov 17, 1982
ANTISERUM TO HUMAN KAPPA
K822666 · DFH
Amico Lab, Inc.
Microbiology · 75d
Cleared Nov 17, 1982
ANTISERUM TO HUMAN LAMBDA
K822667 · DFH
Amico Lab, Inc.
Microbiology · 75d
Cleared Nov 17, 1982
ANTISERUM TO HUMAN IGA
K822668 · DFH
Amico Lab, Inc.
Microbiology · 75d
Cleared Nov 17, 1982
ANTISERUM TO HUMAN IGG
K822669 · DFH
Amico Lab, Inc.
Microbiology · 75d
Cleared Nov 17, 1982
ANTISERUM TO HUMAN IGM
K822670 · DFH
Amico Lab, Inc.
Microbiology · 75d
Cleared Nov 17, 1982
ANTISERUM TO HUMAN GOBULIN
K822671 · DFH
Amico Lab, Inc.
Microbiology · 75d
Cleared Nov 17, 1982
FITC ANTISERA TO HUMAN KAPPA
K822673 · DFH
Amico Lab, Inc.
Microbiology · 75d
Cleared Nov 17, 1982
FITC ANTISERA TO HUMAN LAMBDA
K822674 · DFH
Amico Lab, Inc.
Microbiology · 75d
Cleared Nov 17, 1982
FITC ANTISERA TO HUMAN IGA
K822675 · DFH
Amico Lab, Inc.
Microbiology · 75d
Cleared Nov 17, 1982
FITC ANTISERA TO HUMAN IGG
K822676 · DFH
Amico Lab, Inc.
Microbiology · 75d
Cleared Nov 17, 1982
FITC ANTISERA TO HUMAN IGM
K822677 · DFH
Amico Lab, Inc.
Microbiology · 75d
Cleared Nov 17, 1982
FITC ANTISERA TO HUMAN GOBULIN
K822678 · DFH
Amico Lab, Inc.
Microbiology · 75d
Cleared Nov 17, 1982
FITC ANTISERA TO HUMAN C3
K822679 · DFH
Amico Lab, Inc.
Microbiology · 75d
Cleared Nov 17, 1982
SIGMOIDOSCOPE, FLEXIBLE
K822765 · FAM
Harvard Laboratories
Gastroenterology & Urology · 64d
Cleared Nov 17, 1982
ROTARY VASCULAR KNIFE
K822829 · DWS
Medco Products, Co., Inc.
Cardiovascular · 57d
Cleared Nov 17, 1982
VERIL/PPR PERSONAL PAIN RELIEVER #800
K822929 · GZJ
Verite
Neurology · 44d
Cleared Nov 17, 1982
STREP SELECTIVE AGAR
K822997 · JSI
Granite Diagnostics, Inc.
Microbiology · 36d
Cleared Nov 17, 1982
DENDRITE VM-TRANSCUTANEOUS ELEC. NERVE
K823002 · GZJ
Tri W-G, Inc.
Neurology · 36d
Cleared Nov 17, 1982
DESERT INSYTE-A HYPERTHERMIA SENSOR ACC
K823066 · FLL
Parke-Davis Co.
General Hospital · 30d
Cleared Nov 17, 1982
DIALYSATE ADDITIVES-POWDER/LIQUID
K823103 · KPO
Di-Chem, Inc.
Hematology · 28d
Cleared Nov 17, 1982
RITC-ANTI HUMAN IGA, IGG, KAPPA, LAMBDA
K823121 · DFH
Amico Lab, Inc.
Microbiology · 23d
Cleared Nov 17, 1982
AIR FLOW I
K823133 · EIA
Healthco, Inc.
Dental · 23d
Cleared Nov 17, 1982
AIR FLOW II
K823134 · ELC
Healthco, Inc.
Dental · 23d