Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
159313–159336 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 22, 1982
NON-STERILE REUSABLE NEEDLES
K823255 · FMI
Vertex Medical Corp.
General Hospital · 21d
Cleared Nov 22, 1982
DENTAL FLOSS TIP
K823278 · JES
Sanderson Creative Products Co.
Dental · 19d
Cleared Nov 22, 1982
RESPOND QUADRIFLEX #3129 SINGLE CHANNEL
K823279 · IPF
Medtronic Vascular
Physical Medicine · 19d
Cleared Nov 22, 1982
DISTAFLEX
K823280 · EGG
Duradent Corp.
Dental · 19d
Cleared Nov 22, 1982
HEARING AID UE-10
K823365 · ESD
Unitron Industries, Inc.
Ear, Nose, Throat · 12d
Cleared Nov 18, 1982
BOEHRINGER MANNEHEIM DIAG. ACID PHOSPHA
K823087 · CKB
Boehringer Mannheim Corp.
Chemistry · 30d
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