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
158761–158784 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 18, 1982
GAMBRO PRESSURE MONITOR PRM 10
K822822 · DXS
Gambro, Inc.
Cardiovascular · 28d
Cleared Oct 18, 1982
HEMATOLOGY COMPUTER-INTERFACE, VISCOUNT
K822823 · LKM
Eko Scann AB
Hematology · 27d
Cleared Oct 18, 1982
TICARCILLIN 75MCG. SENSI-DISC
K822832 · JTN
Bd Becton Dickinson Vacutainer...
Microbiology · 27d
Cleared Oct 18, 1982
MODEL 200 SQUID
K822853 · HPT
Synemed, Inc.
Ophthalmic · 21d
Cleared Oct 18, 1982
COAT-A-COUNT TOBRAMYCIN RIA KIT
K822858 · KLB
Diagnostic Products Corp.
Chemistry · 21d
Cleared Oct 18, 1982
BRACHIAL CORONARY GUIDING CATHETER
K822862 · DQO
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 21d
Cleared Oct 18, 1982
SURGI-SCRUB V
K822865 · GEC
Acme United Corp.
General & Plastic Surgery · 21d
Cleared Oct 18, 1982
THERMOSTATIC WATER MIXING VALVE TWV10
K822874 · DWC
Gambro, Inc.
Cardiovascular · 21d
Cleared Oct 18, 1982
MODEL 78534A PATIENT MONITOR
K822876 · DRT
Hewlett-Packard Co.
Cardiovascular · 21d
Cleared Oct 18, 1982
MODEL 78554A DATA MGMT. PLUG-IN MODULE
K822877 · DXG
Hewlett-Packard Co.
Cardiovascular · 21d
Cleared Oct 18, 1982
MODEL 78553A PRESSURE PLUG-IN MODULE
K822878 · DSK
Hewlett-Packard Co.
Cardiovascular · 21d
Cleared Oct 18, 1982
ARTERIO VENOUS SHUNT CANNULA & ADAPTORS
K822880 · FIQ
Renal Systems, Inc.
Gastroenterology & Urology · 27d
Cleared Oct 18, 1982
DIABRITE
K822894 · EJR
Antraco, Inc.
Dental · 20d
Cleared Oct 18, 1982
LATEST RF KIT FOR RHEUMATOID FACTOR
K822905 · DHR
Fisher Scientific Co., LLC
Immunology · 19d
Cleared Oct 15, 1982
BIPOLAR TEMP. PACING CATHETER W/STYLETET
K822002 · LDF
Ziehm International, Inc.
Cardiovascular · 99d
Cleared Oct 15, 1982
BALLOON TEMP. PACING CATHETER
K822003 · LDF
Ziehm International, Inc.
Cardiovascular · 99d
Cleared Oct 15, 1982
ADHESIVE WOUND COVER FILM
K822080 · NAD
Hollister, Inc.
General & Plastic Surgery · 92d
Cleared Oct 15, 1982
VYGON EPIDURAL ANAESTHESIA TRAY
K822691 · CAZ
Exco, Inc.
Anesthesiology · 42d
Cleared Oct 15, 1982
DIGITAL PULSE METER (73 BWS) #HRM-100E
K822692 · DRT
Sanyo Electric, Inc.
Cardiovascular · 38d
Cleared Oct 15, 1982
SIGNAL DISTRIBUTION NETWORK #78581A
K822695 · DRT
Hewlett-Packard Co.
Cardiovascular · 38d
Cleared Oct 15, 1982
SWAN-GANZ BIPOLAR PACING CATHETER
K822723 · DYG
American Edwards Laboratories
Cardiovascular · 38d
Cleared Oct 15, 1982
ROOMATE II
K822789 · CAW
Cryogenic Assoc.
Anesthesiology · 30d
Cleared Oct 15, 1982
DISPOSABLE ELECTRODE #1900
K822798 · DRX
Andover Medical, Inc.
Cardiovascular · 29d
Cleared Oct 15, 1982
MICROFLEX-VENOFLUX
K822836 · FPA
Exco, Inc.
General Hospital · 24d