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
156889–156912 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 08, 1983
ENTERNAL PUMP & ADMIN. SET 430
K831935 · FRN
Imed Corp.
General Hospital · 54d
Cleared Aug 08, 1983
GAMMA STERILIZED CAPILLARY FLOW DIALYZ
K831940 · FKQ
Travenol Laboratories, S.A.
Gastroenterology & Urology · 53d
Cleared Aug 08, 1983
DATA-ZYME URIC ACID PROCEDURE
K831983 · KNK
Data Medical Associates, Inc.
Chemistry · 49d
Cleared Aug 08, 1983
METAL-BACKED ACE TABULAR CUP
K831986 · JDI
Kirschner Medical Corp.
Orthopedic · 49d
Cleared Aug 08, 1983
VISIDEX II REAGENT STRIPS
K831989 · CGA
Miles Laboratories, Inc.
Toxicology · 48d
Cleared Aug 08, 1983
BIOCHECK POSITIVE URINE CONTROL
K831994 · JJW
Helena Laboratories
Chemistry · 48d
Cleared Aug 08, 1983
TRENDO-SCOPE
K831995 · HCS
Gabriel Ent.
Neurology · 48d
Cleared Aug 08, 1983
NML-5010/5020 MULTI-DETECTOR SYSTEM
K832002 · JJJ
Nuclear Medical Laboratories, Inc.
Chemistry · 47d
Cleared Aug 08, 1983
ARGYLE YANKAVER SUCTION TUBE W/CONTROL
K832027 · JOL
Sherwood Medical Co.
General Hospital · 46d
Cleared Aug 08, 1983
MODEL 327T UNIPOLAR CARDIAC PULSE GEN
K832052 · DXY
Cook Pacemaker Corp.
Cardiovascular · 42d
Cleared Aug 08, 1983
EMIT ASSAY AND TOBRAMYCIN
K832055 · LDO
Syva Co.
Chemistry · 42d
Cleared Aug 08, 1983
EMIT AMD GENTAMICIN ASSAY
K832056 · LCD
Syva Co.
Chemistry · 42d
Cleared Aug 08, 1983
VENOUS CATHETER
K832064 · DQY
Cardio Search, Inc.
Cardiovascular · 42d
Cleared Aug 08, 1983
EMIT CAD QUINIDINE ASSAY FOR USE W/
K832096 · LBZ
Syva Co.
Chemistry · 40d
Cleared Aug 08, 1983
IMMULON SUBSTRATE REMOVAWELL STRIPS
K832117 · LIB
Dynatech Corp.
Chemistry · 39d
Cleared Aug 08, 1983
SELF-SEAL STERILIZATION POUCHES
K832128 · KCT
Medical Industries Packaging, Inc.
General Hospital · 38d
Cleared Aug 08, 1983
IMPROVED SILICATH SILICONE ELASTOMER
K832165 · KOD
Travenol Laboratories, S.A.
Gastroenterology & Urology · 34d
Cleared Aug 08, 1983
MULTI-TITER DISPENSER
K832203 · JTC
Hamilton Co.
Microbiology · 32d
Cleared Aug 08, 1983
EPINEED EPIDURAL CATHETER
K832232 · BSO
Terumo Medical Corp.
Anesthesiology · 28d
Cleared Aug 08, 1983
EPINEED EPIDURAL NEEDLE
K832233 · BSP
Terumo Medical Corp.
Anesthesiology · 28d
Cleared Aug 01, 1983
PIPETTE 12 CHANNEL
K831644 · JTC
Organon Teknika Corp.
Chemistry · 70d
Cleared Aug 01, 1983
CLINOVATIVE II DIAGNOSTIC KIT
K831837 · LCP
Pierce Chemical Co.
Hematology · 55d
Cleared Aug 01, 1983
PULSAR #B SINGLE CHANNEL TENS-PULSAR D
K831950 · GZJ
Spembly Medical , Ltd.
Neurology · 47d
Cleared Aug 01, 1983
PENTAX FD-34A DUODENOFIBERSCOPE
K832006 · FDT
Pentax Precision Instrument Corp.
Gastroenterology & Urology · 39d