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

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176,076 results
157273–157296 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 22, 1983
GOULD MODEL IM3000-IM3100 BATTERY POWER
K830885 · DRT
Gould, Inc.
Cardiovascular · 93d
Cleared Jun 22, 1983
MICRO TRAK HSV1 & 2 CULTURE CONFIRMATION
K830953 · GQL
Syva Co.
Microbiology · 89d
Cleared Jun 22, 1983
INDIRECT FLUORESCENT ANTIBODY REAGENTS
K831026 · LHL
Zeus Technologies
Microbiology · 84d
Cleared Jun 22, 1983
BLOOD GAS & FLAME PHOTOMETER INSTRU-
K831075 · CGC
United Diagnostics, Inc.
Chemistry · 79d
Cleared Jun 22, 1983
EVENT-TEST SLIDE
K831383 · JHJ
Icl Scientific
Chemistry · 55d
Cleared Jun 22, 1983
SURGITEK NEPHROSTENT KIT
K831446 · FAD
Mec/Surgitek Products
Gastroenterology & Urology · 48d
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