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
166465–166488 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 28, 1980
ENDOCARD. PACING LEAD STD. LENGTH PL202
K800350 · DTB
Daig Corp.
Cardiovascular · 103d
Cleared May 28, 1980
PACEMAKER, ELECTRODE, PERM. & TEMP.
K800351 · DTB
Daig Corp.
Cardiovascular · 103d
Cleared May 28, 1980
PACEMAKER, ELECTRODE
K800352 · DTB
Daig Corp.
Cardiovascular · 103d
Cleared May 28, 1980
ADAPTER KIT
K800353 · DTD
Daig Corp.
Cardiovascular · 103d
Cleared May 28, 1980
LEAD, SUTURELESS MYOCARDIAL
K800355 · DTB
Daig Corp.
Cardiovascular · 103d
Cleared May 28, 1980
PERMANENT LEAD INTRADUCER
K800356 · DYB
Daig Corp.
Cardiovascular · 103d
Cleared May 28, 1980
SMAC REPLACEMENT REAGENTS/DETERM-URIC-AC
K800672 · CDH
Diagnostic Solutions, Inc.
Chemistry · 63d
Cleared May 28, 1980
SMAC REPLACEMENT REAGENTS/OF BUN-SERUM
K800673 · CDW
Diagnostic Solutions, Inc.
Chemistry · 63d
Cleared May 28, 1980
SMAC REPLACEMENT/TOTAL PROTEIN HUMAN SER
K800674 · CEK
Diagnostic Solutions, Inc.
Chemistry · 63d
Cleared May 28, 1980
REAGENTS FOR DETERM. TOTAL BILIRUBIN
K800675 · CIG
Diagnostic Solutions, Inc.
Chemistry · 63d
Cleared May 28, 1980
REAGENTS FOR DETERM. SODIUM IN HUMAN SUM
K800676 · JGS
Diagnostic Solutions, Inc.
Chemistry · 63d
Cleared May 28, 1980
REAGENTS FOR DETERM. SERUM IRON IN HUMAN
K800677 · JIY
Diagnostic Solutions, Inc.
Chemistry · 63d
Cleared May 28, 1980
REAGENTS FOR DETERM. ALBUMIN IN HUMAN
K800678 · CIX
Diagnostic Solutions, Inc.
Chemistry · 63d
Cleared May 28, 1980
REAGENTS FOR DETERM. ALKALINE PHOSPHATAS
K800679 · CJE
Diagnostic Solutions, Inc.
Chemistry · 63d
Cleared May 28, 1980
REAGENTS FOR DETERM. CALCIUM IN HUMAN
K800680 · CIC
Diagnostic Solutions, Inc.
Chemistry · 63d
Cleared May 28, 1980
REAGENTS FOR DETERM. CHOLESTEROL/SERUM
K800682 · CGO
Diagnostic Solutions, Inc.
Chemistry · 63d
Cleared May 28, 1980
REAGENT FOR DETERM. CHLORIDE IN HUMAN/SM
K800683 · CHJ
Diagnostic Solutions, Inc.
Chemistry · 63d
Cleared May 28, 1980
REAGENT FOR DETERM. CREATINE PHOSPHOKINA
K800684 · JHY
Diagnostic Solutions, Inc.
Chemistry · 63d
Cleared May 28, 1980
REAGENT FOR DETERM. CREATININE IN H/SERU
K800685 · CGX
Diagnostic Solutions, Inc.
Chemistry · 63d
Cleared May 28, 1980
REAGENT FOR DETERM. DIRECT BILIRUBIN
K800686 · CIG
Diagnostic Solutions, Inc.
Chemistry · 63d
Cleared May 28, 1980
REAGENT FOR DETERM. GLUCOSE IN H/SERUM
K800687 · CGA
Diagnostic Solutions, Inc.
Chemistry · 63d
Cleared May 28, 1980
REAGENT FOR DETERM. GLUTAMIC-OXALOACETIC
K800688 · CIT
Diagnostic Solutions, Inc.
Chemistry · 63d
Cleared May 28, 1980
REAGENT FOR DETERM. INORGANIC/PHOSPHORUS
K800690 · CEO
Diagnostic Solutions, Inc.
Chemistry · 63d
Cleared May 28, 1980
REAGENT FOR DETERM. LACTATE/DEHYDROGENAS
K800691 · CFJ
Diagnostic Solutions, Inc.
Chemistry · 63d