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
160537–160560 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 15, 1982
ALGORITHM OF THE ARRHYTHMIA MON. SYS
K820477 · DSI
Hewlett-Packard Co.
Cardiovascular · 52d
Cleared Apr 15, 1982
ARTERIAL CANALIZATION DEVICE
K820516 · DQY
Alimed, Inc.
Cardiovascular · 49d
Cleared Apr 15, 1982
AUTOSPIROMETER HI-498
K820599 · BZG
Medical Equipment Designs, Inc.
Anesthesiology · 42d
Cleared Apr 15, 1982
INFANT MONITOR
K820645 · BZQ
Healthdyne, Inc.
Anesthesiology · 37d
Cleared Apr 15, 1982
PULSE GENERATOR 678 B
K820657 · DXY
Siemens Elema AB
Cardiovascular · 37d
Cleared Apr 15, 1982
CASTLE(R) 2510 & 2610 MINOR SURG. LIGHT
K820681 · FSY
Sybron Corp.
General & Plastic Surgery · 35d
Cleared Apr 15, 1982
CENTRAL VENOUS ACCESS CATHETER
K820736 · DQY
Hemed, Inc.
Cardiovascular · 28d
Cleared Apr 15, 1982
NIHON KOHDEN BLOOD FLOWMETERS #MFV-1100
K820742 · DPW
Nihon Kohden America, Inc.
Cardiovascular · 28d
Cleared Apr 15, 1982
IL MODEL 1301, PH BLOOD GAS SYSTEM
K820744 · CHL
Instrumentation Laboratory CO
Chemistry · 27d
Cleared Apr 15, 1982
MONOJECT SAF-T-LOCK
K820747 · FPA
Sherwood Medical Co.
General Hospital · 27d
Cleared Apr 15, 1982
AMERLEX ESH KIT
K820754 · CGJ
Amersham Corp.
Chemistry · 27d
Cleared Apr 15, 1982
ENZYM-LINKED T3
K820763 · CDP
Icl Scientific
Chemistry · 24d
Cleared Apr 15, 1982
IVAC MODEL 160 AIR-IN-LINE SENSOR
K820764 · FRN
Y
General Hospital · 24d
Cleared Apr 15, 1982
PLEURAL DRAINAGE RESERVOIR
K820765 · GCX
Innovative Surgical Products, Inc.
General Hospital · 24d
Cleared Apr 15, 1982
CANNUOATED TROCHAR
K820776 · HRX
The Anspach Effort, Inc.
Orthopedic · 23d
Cleared Apr 15, 1982
CASTLE MICROCOMPUTER STERILIZER CONTROL
K820783 · FLF
Sybron Corp.
General Hospital · 23d
Cleared Apr 15, 1982
CARDIAC MONITOR - RATE ALARM
K820825 · DRT
Hewlett-Packard Co.
Cardiovascular · 21d
Cleared Apr 15, 1982
PHOSPHORUS IL
K820832 · CED
American Monitor Corp.
Chemistry · 20d
Cleared Apr 15, 1982
MARK III OXYGEN WALKER SYSTEM
K820836 · BYJ
Union Carbide Corp.
Anesthesiology · 20d
Cleared Apr 15, 1982
MECRON CONCAVEX FLEXIBLE INTRAMEDULLARY
K820852 · HSB
Serrano Intl.
Orthopedic · 20d
Cleared Apr 15, 1982
NORTON MANIFOLD
K820864 · DTL
Norton Performance Plastics Corp.
Cardiovascular · 17d
Cleared Apr 15, 1982
MARQUETTE OPTION II ECG ANALYSIS COMPUT
K820885 · LOS
Marquette Electronics, Inc.
Cardiovascular · 16d
Cleared Apr 15, 1982
COLD ROLL
K820901 · IME
North Bank Labs, Inc.
Physical Medicine · 15d
Cleared Apr 15, 1982
PBC NEEDLE BY NIPRO MED. INDUSTRIES
K820911 · FMI
Philadelphia Biologics Center
General Hospital · 14d