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
149929–149952 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 14, 1985
CARDIOTOMY RESERVOIR W/FILTER BCR-2500
K844367 · DTN
American Bentley
Cardiovascular · 62d
Cleared Jan 14, 1985
FOREGGER DOME VALVES
K844421 · BSZ
Puritan Bennett Corp.
Anesthesiology · 60d
Cleared Jan 14, 1985
M/D4 W/CHARGER (CARDIOPAC 3M11)
K844447 · LDD
Datascope Corp.
Cardiovascular · 59d
Cleared Jan 14, 1985
KHM 2000 DRIP WATCHER
K844556 · FLN
The Timeter Group
General Hospital · 54d
Cleared Jan 14, 1985
INFANT LIMB ELECTRODE
K844632 · DRX
Sentry Medical Products, Inc.
Cardiovascular · 48d
Cleared Jan 14, 1985
TRACHEAL TUBE W/AIRWAY INTUBATOR
K844746 · BTR
Sheridan Catheter Corp.
Anesthesiology · 39d
Cleared Jan 14, 1985
SURGICAL DRAPES
K844802 · KKX
Procter & Gamble Mfg. Co.
General Hospital · 34d
Cleared Jan 14, 1985
SECURLINE SURGICAL SKIN MARKER 1000
K844865 · FZZ
Precision Dynamics Corp.
General & Plastic Surgery · 31d
Cleared Jan 14, 1985
FIBERLASE 100 MEDICAL LASER SYSTEM
K844869 · LLO
Laser Media
Anesthesiology · 31d
Cleared Jan 14, 1985
HOLTER CURA-LITE RECORDER
K844977 · DSH
Cardionostics, Inc.
Cardiovascular · 19d
Cleared Jan 14, 1985
MARTANIQUE 7-TUBE RUVA HOME SOLARIUM
K845028 · FTC
Bainbridge Trading Co., Ltd.
General & Plastic Surgery · 18d
Cleared Jan 14, 1985
SOLAR TAN - SOLARIA IV
K850042 · FTC
Sola-Tan Intl.
General & Plastic Surgery · 7d
Cleared Jan 10, 1985
HORIZON ECG SYSTEM
K823844 · DSI
Beckman Instruments, Inc.
Cardiovascular · 751d
Cleared Jan 10, 1985
MULTILITH PULSE GENERATORS, 1141 & 2141
K842193 · DXY
Ela Medical, Inc.
Cardiovascular · 220d
Cleared Jan 10, 1985
CEREGROTRAC
K842784 · GWQ
Advanced Instruments, Inc.
Neurology · 177d
Cleared Jan 10, 1985
HEARING AID, UNITRON UE12-PP
K843245 · ESD
Unitron Industries, Inc.
Ear, Nose, Throat · 143d
Cleared Jan 10, 1985
COFIELD SHOULDER SYSTEM
K843624 · KWS
Richards Medical Co., Inc.
Orthopedic · 122d
Cleared Jan 10, 1985
ROD FOR RACHIS SURGERY
K843687 · KWP
Sofamor Co.
Orthopedic · 114d
Cleared Jan 10, 1985
I.V. START KIT & OBSTETRICAL KIT
K843724 · KKX
E.M. Adams
General Hospital · 108d
Cleared Jan 10, 1985
POROUS COATED TITANIUM KNEE PROSTHES-
K843907 · JWH
Johnson & Johnson Professionals, Inc.
Orthopedic · 99d
Cleared Jan 10, 1985
INTRAVASCULAR BLOOD GAS SYSTEM
K843912 · CCE
Cardiovascular Devices, Inc.
Anesthesiology · 99d
Cleared Jan 10, 1985
STIMTECH SD CLINICIAN 6090 #78-8055
K844212 · GZJ
Codman & Shurtleff, Inc.
Neurology · 71d
Cleared Jan 10, 1985
STIMTECH SD PATIENT 6089 #78-8050
K844213 · GZJ
Codman & Shurtleff, Inc.
Neurology · 71d
Cleared Jan 10, 1985
NOVAMETRIX 811 TRANSCO2M PORTABLE TRANSCUTANEOUS 2
K844253 · KLK
Novametrix Medical Systems, Inc.
Anesthesiology · 69d