FDA 510(k) clearances — page 1046
clearances on record, most recent first.
Clearances — page 1046
104,501–104,600 of 176,637- K950915 — ABBOTT AXSYM II SYSTEM
- K950934 — MPM HYDROGEL DRESSING
- K951167 — EMS I.V. START KIT
- K951182 — RYDER CONTACT LENS CASE MODEL 10670
- K951214 — STERILE EQUIPMENT COVER
- K951286 — AXSYM BENZODIAZEPINES
- K951288 — AXSYM CANNABINOIDS
- K951625 — KARL STORZ KOH NEEDLE HOLDERS, FORCEPS FOR SUTURING, SUTURE SCISSORS, TISSUE PROBES, INJECTION NEEDLE, IRRIGATION INSTRT
- K951731 — NEZHAT-DORESY ELECTROSURGICAL HAND CONTROL ATTACHMENTS
- K951860 — HOWMEDICE BONE PLUG
- K951934 — PFC CEMENT RESTRICTOR
- K924306 — PERCUTANEOUS ENDOSCOPIC GASTROSTOMY
- K925255 — TRAX(TM) CD4 TEST KIT
- K926073 — ULTRAVAC-NG(TM) NASOGASTRIC SUMP SUCTION TUBE
- K942346 — IMAGERT
- K943686 — IL TEST BETA-2MICROGLOBULIN
- K943929 — DATAGLOVE AND MOVEMENT ANALYSIS SYSTEM (MAS)
- K943961 — THE MODEL ACAPPELLA IN THE EAR HEARING AID
- K944280 — TRANSAMERICAN CLASSIC TENS
- K944684 — POLYSCAN DIGITAL SCANNER
- K945022 — APOFIX CERVICAL SPINE FIXATION
- K945131 — IMAGYN INTRAUTERINE INSEMINATION DEVICE
- K945614 — ADD POWER FAMILY , MICRO ADDSTAT
- K946188 — CCDS MAESTRO(R) II SERIES 200 CADIAC PACEMAKER
- K946218 — MARDX ENA EIA TEST SYSTEM
- K946228 — CROSS PIN SCREW SYSTEM
- K950010 — DARWIN KNEE SYSTEM (CRUCIATE SUBSTITUTING) POROUS COATED AND NON-POROUS COATED
- K950110 — MARDX MITOCHONDRIA EIA TEST SYSTEM
- K950128 — TOTAL PROTEIN TEST (TPRO) ITEM XXXXX/R1. R2
- K950202 — RINGLOC CONSTRAINED LINER
- K950242 — ARGUS ARTHROSCOPY INSTRUMENT SYSTEM
- K950270 — NMI SOFTWARE
- K950420 — FETALGARD 3000 - MODELS IP1, IP2, AP2 AND AP3
- K950524 — NICHOLS INSTITUTE DIAGNOSTICS DHEA-S CHEMILUMINESCENCE IMMUNOASSAY
- K950564 — RICH-MAR US-II ULTRASOUND
- K950586 — AVD INTIMAX THROMBECTOMY CATHETER
- K950751 — TECOTHANE 75D POLYURETHANE RESIN FOR PULSE GENERATOR CONNECTOR MODULES
- K950752 — ACS TORQUE DEVICE, ACS GUIDE WIRE INTRODUCER, ACS GUIDE WIRE ACCESSORY KITS
- K950753 — CHAKOFF ENDOSCOPY (CAMERA TELEVISION ENDOSCOPIC WITHOUT AUDIO
- K951085 — PADGETT AIR DERMATOME, MODEL A
- K951326 — BIOPSY DEVICE ACCESSORY
- K951358 — SIRESKOP SX
- K951396 — KODAK X-OMAT 3000 RA PROCESSOR
- K951397 — KODAK X-OMAT 5000 RA PROCESSOR
- K951427 — AMERICAN DENTAL PRODUCTS (ADP), COMPOSITE RESTORATIVE MATERIAL
- K951548 — ACE AMYLASE REAGENT
- K951586 — T-UPTAKE EIA TEST
- K951635 — BECKMAN IMMUNOGLOBULIN G (IGG) REAGENT, URINE APPLICATION, URINE PROTEIN CALIBRATOR, CONTROL
- K951748 — COAT-A-COUNT LH IRMA
- K951749 — BIO-LIPID LIPID CONTROL- LEVEL 1,2 AND 3
- K951818 — HICHEM ALT REAGENT KIT
- K951826 — KARL STORZ TRACHEAL HIGH FREQUENCY RESECTOSCOPE
- K951907 — NAVARRE LOCKING PIGTAIL UNIVERSAL DRAINAGE CATHETER
- K951914 — HYDRACARE ABSORBENT WOUND DRESSING
- K922528 — CMS SYSTEM
- K941708 — COBE CENTRYSYSTEM CS500 DIALYZER
- K942347 — NELLCOR SYMPHONY PULSE OXIMETER MODEL N-3000
- K943215 — DISPOSABLE AUDIOMETER EARPHONE CUSHION COVER
- K943602 — DI-2000
- K943714 — MICRO MULTILEAF COLLIMATOR
- K943798 — MRH-1500
- K943939 — NON-CONTACT TONOMETER T-2
- K943994 — PACS EQUIPMENT
- K944196 — IMWXDOP IR
- K944262 — ECG MONITOR
- K945148 — MECHANICAL WHEELCHAIR- AVENGER
- K945149 — MECHANICAL WHEELCHAIR- CHALLENGER
- K945150 — MECHANICAL WHEERCHAIR- ECLIPSE
- K945151 — MECHANICAL WHEELCHAIR- G-FORCE
- K945153 — MECHANICAL WHEELCHAIR- LIL DIPPER
- K945175 — MECHANICAL WHEELCHAIR 890.3850
- K945193 — ALL-IN-ONE TWO CHAMBER CONTAINER
- K945217 — HYDROGEL DRESSING
- K945907 — KARL STORZ SEMI-RIGID MICRO-ENDOSCOPES AND ACCESSORIES FOR ADULT AND PEDIATRIC ENDOSCOPIC UROLOGY PROCEDURES
- K946128 — SIMULIX-HP
- K950423 — MINI IMAGER
- K950501 — DANEK RIGID ARTHROSCOPE
- K950561 — KSEA DISPOSABLE TUBING SET FOR THE ARTHROPUMP
- K950632 — INNERDYNE STEP TROCAR EXPANDABLE PORT, STEP
- K950658 — INNERDYNE STEP TROCAR EXPANDABLE PORT, STEP:
- K950815 — CHAMPION
- K950913 — PERFECT, ENT SET, PRAKTIKANT, DE LUXE
- K951067 — RESOUND ED4-C CANAL PERSONAL HEARING SYSTEM W/REMOTE CONTROL OPTION (RESOUND PHS ED4-C)
- K951068 — RESOUND ED4-M MINI-CANAL PERSONAL HEARING SYSTEM W/REMOTE CONTROL OPTION (RESOUND PHS ED4-M)
- K951168 — CRYSTAL
- K951181 — RYDER CONTACT LENS CASE
- K951184 — OTI MODEL 78-60
- K951220 — HEMA-GLU
- K951272 — RELACS 7000
- K951426 — AMERICAN DENTAL PRODUCTS (ADP), VISIBLE LIGHT CURE COMPOSITE DENTAL RESTORATIVE MATERIAL
- K951526 — TREBAY IRRGATED CUTTER BLADE
- K951530 — PROSYS URIHESIVE SYSTEM LA
- K951583 — PERMAQUIK BONDING PRIMER
- K951648 — MIST ENDOSCOPIC NEEDLES
- K951695 — OPERAND* ULTRASOUND TRANSMISSION GEL
- K951702 — FMS HIGH FLOW ARTHRO-SHEATH
- K951715 — ENDO IRRIGATOR 2211, INCLUDING TUBING
- K951847 — AVANTGARDE
- K951912 — DISOPOSABLE & RESUABLE MONPOLAR CORD
- K924312 — NURTURE III
Data sourced from openFDA. This site is unofficial and independent of the FDA.