FDA 510(k) clearances — page 1341
clearances on record, most recent first.
Clearances — page 1341
134,001–134,100 of 176,637- K883454 — MC6700 MULTI-CHANNEL ELECTROCARDIOGRAPH
- K885019 — BEMIS STERILE-CASE FOR USE W/ETHYLENE OXIDE STERI.
- K885235 — SAFE-DRAW(TM) BLOOD SAMPLING RESERVOIR & ACCESS.
- K885262 — POLYHESIVE MONITORING AND DIAGNOSTIC ELECTRODES
- K885296 — MINIFLOW DISPOSABLE PRESSURE TRANSDUCER 63-600F
- K881344 — ACA ETHYL ALCOHOL (ALC) ANALYTICAL TEST PACKS
- K882517 — RODENSTOCK SCANNING LASER OPHTHALMOSCOPE
- K882826 — SOFTRAC-PTA PERIPHERAL DILATATION CATHETER
- K883379 — MODELS 4000/4900/6000/8000/8900 ND:YAG & 1700 CO2
- K883720 — TREND(R) EMERGE(TM) TOXOPLASMA IGG ELISA
- K883898 — MAGNETOM 42 SP AND MAGNETOM 63 SP
- K884017 — ROTACUBE
- K884090 — LUNDY VAPORIZER SYSTEM
- K884169 — DU PONT ANALYST THYROID ROTOR
- K884182 — SURGILASE YAG 100 SURGIPROBES & SURGISCALPEL
- K884340 — AMX-110, AMX-II AND AMX-III
- K884534 — PALL HEPCHEK (TM) HEPARIN ABSORPTION FILTER
- K884561 — KOENIG TOTAL TOE IMPLANT
- K884591 — EBV-VCA ANTIBODY (IGG)
- K884618 — NOVA CELLTRAK 11 AUTO. HEMA. ANALYZER, CALIBRATORS
- K884640 — CARDIOPLEGIA OVERPRESSURE VALVE CPOP-350 & 700
- K884659 — SARNS 9000 WITH CENTRIFUGAL PUMP OPTION
- K884787 — ACCULITE-PPL 5
- K884844 — PLEUR-EVAC(R) A-7002--ADULT/PEDIATRIC DRAINAGE
- K885030 — STANDARD ADMINISTRATION SETS
- K885048 — ACCESS R-CLONE ANA PROFILE ASSAY
- K885125 — KRUPIN EYE VALVE W/SCLERAL BUCKLE
- K885142 — GAUZE SWABS, NON-STERILE
- K885275 — ASSENAT-BLESCHET SUNGLASSES
- K890001 — DOUBLE ANTIBODY SERUM BENZODIAZEPINES
- K890006 — BAXTER STERILE TOWEL
- K890014 — DISPOSABLE COLOR-CUFFS
- K890071 — STERILE LACERATION TRAY
- K890073 — MODERN LATEX STERILE SURGICAL GLOVES
- K890090 — DANEK IRRIGATING BURR (DIB) SET
- K890098 — KLEEN TEST O.R. KIT
- K890103 — BARD TAB ECG MONITORING ELECTRODE
- K890108 — MODIFIED CUSHION-FLEX(TM)
- K890119 — BR-S601MU (SURGICAL VIDEO RECORDER)
- K890148 — ATS TB RAPID STAIN SET PRODUCT #034-45
- K883327 — CLINISTAT BUN (BLOOD UREA NITROGEN) REAGENT TEST
- K884146 — ALBUWELL
- K884600 — TECHNICON SYSTEM RA-100/ASSIST MAGNESIUM
- K884703 — TOTAL PROTEIN TEST (TP) ITEM #65670
- K884704 — URIC ACID TEST (URIC) ITEM #65620
- K884883 — 28 ADDITIONAL ALLERGEN MODULES FOR ALASTAT(TM)
- K890002 — COAT-A-COUNT (TM) THEOPHYLLINE
- K890030 — NEW LOW LEVEL DRUG MIXTURE CONTROL
- K890041 — V-TREND TARGET IM TEST
- K882609 — MODELS M1175A & M1176A COMPONENT MONITORING SYSTEM
- K883905 — ARROW PNEUMOTHORAX KIT, AK-01500
- K884434 — VORTECH'S MEDICAL IMAGING GATEWAY
- K884464 — SPIROMETRICS MODEL 2200 SM200 FLOW SENSOR
- K884472 — AIR-ELECTRONIC AIR CLEANER (FILTER)
- K884540 — ETV, ELECTRONIC VISION AID
- K884615 — ATI-PYMAH DISPOSABLE STEAM BIOLOGICAL TEST PACK
- K884653 — RACESTYPTINE
- K884752 — KETAC-GLAZE
- K885217 — DISCARD DENTAL EXPLORER
- K885218 — DISCARD DENTAL MIRROR
- K885219 — DENTAL DRESSING PLIERS
- K884410 — OMNIFIT TOTAL KNEE SERIES III,IV & POST. STAB. FEM
- K884483 — CRUCIOMETER
- K884500 — ALTA NON-REAMED TIBIAL ROD
- K884502 — USCI 8F EXTRA LARGE LUMEN GUIDE CATHETER
- K884583 — BTE HEARING AID SIEMENS MODEL 284PP-ASP
- K884670 — EXEL 1800 AND 1800E CT SCANNER
- K884671 — EXEL 2400 AND 2400 ELITE CT SCANNERS
- K885346 — NON-STERILE VINYL GLOVES
- K881323 — CURIETRON 192 LOW DOSE RATE
- K882824 — TAKEDA MEDICAL AUTO. DIGITAL BLOOD PRES. MONITOR
- K882825 — TAKEDA MEDICAL AUTO. DIG. BLOOD PRES. METER W/PRIN
- K883069 — MINIMON 7134B PATIENT MONITOR
- K883109 — MINIMON 7136B PATIENT MONITOR
- K883214 — THORACIC SUPPORT SYSTEM
- K883402 — EXCALIBUR CONTROLLER (WORK LOAD PROGRAMMER)
- K883440 — E550 ELECTROCARDIOGRAPH
- K883743 — MEDTRONIC MODEL 4058 PACING LEAD
- K884135 — DM100 (DISTAL MONITOR - 100)
- K884158 — THE SYSTEM, SARA DIGICAP PLUS OHMEDA MINX OXIMETER
- K884398 — OMNIFIT TOTAL KNEE SERIES II TIBIAL INSERTS
- K884440 — TECNOL VARIABLE TENSION BANDAGE
- K884484 — MAGNETIC RESONANCE DIAGNOSTIC HELMHOLTZ NECK COIL
- K884490 — INTRODUCER SAFETY SYRINGE
- K884520 — SERVO VENTILATOR 900E
- K884539 — HOLTER 24-HOUR ECG PLAYBACK, MODEL 150
- K884663 — IMPULSE EPIDURAL ELECTRODE
- K884678 — ESP 3-PHASE X-RAY GENERATORS
- K884707 — FIAGEN DIGOXIN TIME-RESOLVED FLUOROIMMUNOASSAY KIT
- K884708 — FIAGEN HFSH TIME-RESOLVED FLUOROIMMUNOASSAY KIT
- K884730 — SHILEY PERC TRACHEOSTOMY SYSTEM
- K884769 — MODEL 654 A SODIUM, POTASSIUM & LITHIUM ISE ANALY
- K884948 — MODEL 3587A RESUME EPIDURAL LEAD
- K884973 — FR6000 FLOWMETER
- K885022 — MAGNESIUM TEST ITEM NUMBER: SR1019
- K885033 — MODEL 3487A PISCES EPIDURAL LEAD
- K885314 — HPD STERILE HUMIDIFYING CHAMBER
- K881314 — PROMO-RIST C.P.M.
- K882344 — ELECTR-TRANSBLOTTER
- K882633 — ENSONIQ SOUND SELECTOR, BTE DIGITAL PROG. HRNG AID
Data sourced from openFDA. This site is unofficial and independent of the FDA.