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
160393–160416 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Apr 29, 1982
MOISTURE TRAP
K820936 · BYH
Dhd Medical Products Div. Diemolding...
Anesthesiology · 27d
Cleared Apr 29, 1982
AS 70 VOLUMETRIC INFUSION PUMP
K820946 · FRN
Narco Scientific
General Hospital · 23d
Cleared Apr 29, 1982
P-S BERLIN VESSEL CLAMP
K820949 · DXC
Pudenz-Schulte Medical Research Corp.
Cardiovascular · 23d
Cleared Apr 29, 1982
OPTI-MIST
K820952 · CAF
Corpak Co.
Anesthesiology · 23d
Cleared Apr 29, 1982
DIATHERMIC HANDLE FOR BIOPSY FORCEPS
K820971 · GEI
Mill-Rose Laboratory
General & Plastic Surgery · 23d
Cleared Apr 29, 1982
EKG MONITORS, VARIOUS MODELS
K820986 · DXH
Dart Medical Equipment
Cardiovascular · 23d