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
161233–161256 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 03, 1982
SKATRON REPEATING DISPENSER
K821034 · JQW
Skatron, Inc.
Chemistry · 20d
Cleared May 03, 1982
UNI-PUMP 200
K821039 · JQW
Scientific Mfg. Industries, Inc.
Microbiology · 20d
Cleared May 03, 1982
RAPID SST
K821040 · JTO
Mds Laboratories, Inc.
Microbiology · 20d
Cleared May 03, 1982
IVAC 630 & VOLUMETRIC INFUSION PUMP
K821047 · FRN
Y
General Hospital · 19d
Cleared May 03, 1982
LIQUID-STAT TM AST-UV LIQUID ENZUNE
K821048 · CKA
Beckman Instruments, Inc.
Chemistry · 18d
Cleared May 03, 1982
715 DELTA TERMINAL
K821058 · JQP
Corning Medical & Scientific
Chemistry · 18d
Cleared May 03, 1982
ACE ALBUMIN CALIBRATOR
K821061 · JIS
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 18d
Cleared May 03, 1982
INSPIRON NEONATAL VENTILATOR CIRCUIT
K821064 · BZO
C.R. Bard, Inc.
Anesthesiology · 18d
Cleared May 03, 1982
M T M CIRCUIT
K821086 · CAI
Medical Technology Mix, Inc.
Anesthesiology · 14d
Cleared Apr 29, 1982
DIGITAL CLINICAL THERMOMETER
K820024 · FLL
Faith & Firsts Enterprises Co., Ltd.
General Hospital · 114d
Cleared Apr 29, 1982
ADAPTATION OF KANTRON 40 CC. PDLIAB
K820166 · DSP
Kontron Instruments, Inc.
Cardiovascular · 98d
Cleared Apr 29, 1982
BIGSTON TRANSCUTANEOUS NERVE STIMULAT
K820326 · GZJ
Canadian Medical Products
Neurology · 80d
Cleared Apr 29, 1982
QUINTON Q2000 ETT MONITORING SYSTEM
K820438 · DSI
Quinton, Inc.
Cardiovascular · 71d
Cleared Apr 29, 1982
BIOPSER
K820519 · HFB
Advanced Biomedical Instruments
Obstetrics & Gynecology · 63d
Cleared Apr 29, 1982
LPS 1118
K820650 · KCW
L.P. Systems Corp.
General & Plastic Surgery · 51d
Cleared Apr 29, 1982
MODEL 860-1 VERI/PROBE
K820651 · GZJ
Verite
Neurology · 51d
Cleared Apr 29, 1982
AUTOMATIC DIALYZER REPROCESSOR #ADR-22
K820695 · LIF
Texas Medical Devices, Inc.
Gastroenterology & Urology · 48d
Cleared Apr 29, 1982
BOUNDARY SINGLE-USE CRANIOTOMY SHEET
K820758 · KKX
The Buckeye Cellulose Corp.
General Hospital · 38d
Cleared Apr 29, 1982
THERMO-K
K820814 · DWJ
American Medical Systems, Inc.
Cardiovascular · 36d
Cleared Apr 29, 1982
CARDIO REVUE CENTER
K820820 · DXG
Diasonics, Inc.
Cardiovascular · 36d
Cleared Apr 29, 1982
TANDEM HCG KIT
K820822 · JHI
Hybritech, Inc.
Chemistry · 36d
Cleared Apr 29, 1982
EVENTMASTER 2
K820856 · DSI
Instruments For Cardiac Research
Cardiovascular · 31d
Cleared Apr 29, 1982
SEPTISLEEVE
K820883 · DYG
Argon Medical Corp.
Cardiovascular · 30d
Cleared Apr 29, 1982
ELECTRICAL MUSCLE STIMULATOR
K820884 · IPF
Nitron Electronics
Physical Medicine · 30d