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
156433–156456 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 22, 1983
HCG-CHECK
K831466 · JHJ
Diagnostic Technology, Inc.
Immunology · 47d
Cleared Jun 22, 1983
B HCG-CHECK
K831468 · JHJ
Diagnostic Technology, Inc.
Immunology · 47d
Cleared Jun 22, 1983
PTH MR
K831470 · CEW
Ramco Laboratories, Inc.
Chemistry · 47d
Cleared Jun 22, 1983
LYPHOCHEK HEMOGLOBIN AIC CONTROL HUMAN
K831478 · LCP
Bio-Rad
Chemistry · 44d
Cleared Jun 22, 1983
PARAMAX ALKALINE PHOSPHATASE REAGENT-
K831480 · CJE
American Dade
Chemistry · 44d
Cleared Jun 22, 1983
URI-TEST 3, INLAB REAGENT STRIPS-URINAL
K831498 · JIL
Laprol Scientific, Inc.
Chemistry · 42d
Cleared Jun 22, 1983
AUTO CAROUSE/WASH SOLUTION CONCENTRATE
K831518 · JJE
Syva Co.
Chemistry · 41d
Cleared Jun 22, 1983
RPMI-1640 MEDIUM W/L-GLUTAMINE &
K831519 · KIT
Sigma Chemical Co.
Chemistry · 41d
Cleared Jun 22, 1983
PARAMAX CREATINE KINASE REAGENT
K831537 · CGS
American Dade
Chemistry · 44d
Cleared Jun 22, 1983
FIAX IGA TEST KIT
K831607 · CZN
Intl. Diagnostic Technology
Immunology · 35d
Cleared Jun 22, 1983
FIAX IGM TEST KIT
K831608 · DFT
Intl. Diagnostic Technology
Immunology · 35d
Cleared Jun 22, 1983
RIM BETA LACTAMASE TEST
K831654 · JTO
Austin Biological Laboratories
Microbiology · 30d
Cleared Jun 22, 1983
SPECTRUM-10
K831672 · JSS
Austin Biological Laboratories
Microbiology · 30d
Cleared Jun 20, 1983
ORTHO WRAP
K830622 · FQM
Fast Wrap Co., Inc.
General Hospital · 112d
Cleared Jun 20, 1983
MEASURE-UP MUSCLE STIMULATOR
K831003 · IPF
Measure-Up Intl., Inc.
Physical Medicine · 83d
Cleared Jun 20, 1983
MORWEL CANNULA
K831520
Morwel Corp.
General & Plastic Surgery · 39d
Cleared Jun 20, 1983
UNI-THANE
K831611 · NAD
Carapac Systems, Inc.
General & Plastic Surgery · 32d
Cleared Jun 18, 1983
CIRCA MED TWO-CHANNEL
K830830 · DSI
Circadian, Inc.
Cardiovascular · 94d
Cleared Jun 17, 1983
YELLOW IRIS TM
K830220 · KQO
Intl. Remote Imaging Systems
Pathology · 144d
Cleared Jun 17, 1983
URETERAL STONE EXTRACTOR CATHETER
K831244 · KOD
American Edwards Laboratories
Gastroenterology & Urology · 60d
Cleared Jun 17, 1983
DEMAND ANALYZER SYSTEM
K831477 · JJE
Worthington Diagnostic Systems
Chemistry · 39d
Cleared Jun 17, 1983
GLUCOSE 3, INLAB REAGENT STRIPS-URINALY
K831499 · JIN
Laprol Scientific, Inc.
Chemistry · 37d
Cleared Jun 17, 1983
PARAMAX AMALINE REAGENT
K831536 · JFJ
American Dade
Chemistry · 39d
Cleared Jun 17, 1983
GONORRHEA TRANSETTE 1 & 3
K831579 · JTW
Spectrum Diagnostic, Inc.
Immunology · 31d