FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
129697–129720 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 18, 1989
INAMED PRO-TEC SILICONE SURGICAL GLOVES
K894073 · KGO
Inamed Development Co.
General Hospital · 102d
Cleared Sep 18, 1989
BIOTEL MICROALBUMINURIA (TM)
K894169 · JIR
American Diagnostic Corp.
Chemistry · 95d
Cleared Sep 18, 1989
TEMP BOND NE
K894219 · EMA
Kerr Corporation (Danbury)
Dental · 91d
Cleared Sep 18, 1989
DEVILBISS MODEL 7351 SERIES
K894424 · BYE
Devilbiss Health Care, Inc.
Anesthesiology · 63d
Cleared Sep 18, 1989
MODIFIED CLAIMS FOR FEF(TM) END-TIDAL CO2 DETECTOR
K894429 · CCK
Fenem, Inc.
Anesthesiology · 63d
Cleared Sep 18, 1989
DAIG ELECTROPHYSIOLOGY CATHETER
K894500 · DRF
Daig Corp.
Cardiovascular · 61d
Cleared Sep 18, 1989
FPR THEOPHYLLINE CALIBRATOR KIT
K894530 · DLJ
Colony Laboratories, Inc.
Toxicology · 60d
Cleared Sep 18, 1989
DELFIA FREE THYROXINE (FT4) KIT
K894605 · CEC
Pharmacia, Inc.
Chemistry · 60d
Cleared Sep 18, 1989
ASC-952 PHYSIOLOGICAL AMPLIFIER
K894735 · DRR
Astro-Med, Inc.
Cardiovascular · 53d
Cleared Sep 18, 1989
T-SCOPE, TELEMETRIC PRECORDIAL STETHOSCOPE
K894757 · BZT
Louisville Laboratories, Inc.
Anesthesiology · 53d
Cleared Sep 18, 1989
ANESTHESIA BREATHING BAGS SIZES 1/2, 1,2,3 LITER
K894906 · BTC
Med-Tek Corp.
Anesthesiology · 48d
Cleared Sep 18, 1989
DA-100HS
K894913 · JAA
Fischer Imaging Corp.
Radiology · 47d
Cleared Sep 18, 1989
NR5000 E.C.G. AND PULSE OXIMETER MONITOR
K894919 · DRT
Nirad , Ltd.
Cardiovascular · 47d
Cleared Sep 18, 1989
MILENIA(TM) PROLACTIN (MKPR1,5)
K895003 · CFT
Diagnostic Products Corp.
Chemistry · 41d
Cleared Sep 18, 1989
SLT CONTACT LASER SYSTEMS
K895093 · GEX
Surgical Laser Technologies, Inc.
General & Plastic Surgery · 35d
Cleared Sep 18, 1989
SPINOCAN(R) CONTINUOUS SPINAL TRAY
K895192 · CAZ
Burron Medical, Inc.
Anesthesiology · 38d
Cleared Sep 18, 1989
CALIFORNIA COMFORT FOUR WHEEL
K895384 · IQC
Jubilee Scooters, Inc.
Physical Medicine · 19d
Cleared Sep 15, 1989
LATEX EXAMINATION GLOVES
K890803 · LYY
A-Tek Medical Supply
General Hospital · 211d
Cleared Sep 15, 1989
SUNNY TEX (PATIENT EXAMINATION GLOVES)
K892021 · LYY
P.T. Indotama Megah Indah Rubber
General Hospital · 169d
Cleared Sep 15, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K892095 · LYY
Madafair , Ltd.
General Hospital · 165d
Cleared Sep 15, 1989
GEN-PROBE PACE SYSTEM URINE SCREEN
K892216 · JXA
Gen-Probe, Inc.
Microbiology · 165d
Cleared Sep 15, 1989
DENTAL PIK
K892861 · EKS
U.S. Dentek Corp.
Dental · 150d
Cleared Sep 15, 1989
PATIENT EXAMINATION GLOVES
K892992 · LYY
Cypress Ent.
General Hospital · 156d
Cleared Sep 15, 1989
PATIENT EXAMINATION GLOVES
K893020 · LYY
Dover Products, Inc.
General Hospital · 155d