FDA 510(k) clearances — page 897
clearances on record, most recent first.
Clearances — page 897
89,601–89,700 of 175,890- K981071 — ML MICROKERATOME
- K981078 — TRANSTRACHEAL AUGMENTED VENTILATION OXYGEN CONCENTRATOR MODEL NUMBER TTAV 1000
- K981534 — VIPERCAM
- K981708 — DENTAL PORCELAIN-VARIOUS
- K982269 — CLEAR HUB SPINAL NEEDLE 14GA, 16GA, 17GA, 18GA, 20GA, 21GA, 22GA, 25GA, 26GA AND 27GA
- K971322 — CORE AND COIL ASSEMBLY GUIDEWIRE
- K972908 — SANDS SERIES III HYPERBARIC CHAMBER
- K973154 — UBI MAGIWEL MARIJUANA METABOLITES
- K973456 — SPIROBANK PORTABLE PC BASED SPIROMETER
- K974343 — DADE INNOVIN
- K980365 — GOODKNIGHT 418 CPAP SYSTEM
- K980522 — REFRACTEC MCS-100
- K980596 — VCA IGM ELISA TEST SYSTEM
- K980635 — DAKO MOUSE ANTI-HUMAN B-CELL, CD19/RPE-CY5, CLONE HD37
- K980912 — VCA IGG ELISA TEST SYSTEM
- K980966 — SUPERGLOVES POWDERED NITRILE
- K981083 — RETROX RX 53-BP, RETROX RX 60-BP, RETROX RX 45-JBP, RETROX RX 53-JBP MODEL NUMBERS 124 396, 124 397, 124 395, 124 000
- K981444 — BIOSTRIP HCG I-ONE STEP PREGNANCY TEST ACCUSTRIP HCG 1-ONE STEP PREGNANCY TEST STRIP
- K981493 — MTM BIOSCANNER C TEST STRIPS MODEL NUMBER BSA 200, BSA 210, BSA 220
- K981654 — TIBC
- K981748 — WIELISA ANCA SCREENING KIT TEST SYSTEM
- K981750 — WIELISA ANTI-GBM, ANCA SCREENING KIT TEST SYSTEM
- K981760 — PLAYTEX SILK GLIDE ODOR ABSORBING FLUSHABLE CARDBOARD TAMPONS #13598
- K981799 — CREA
- K981814 — ALBP
- K981920 — AMM
- K981926 — ETHYL ALCOHOL CLINICAL STANDARD SOLUTIONS
- K981943 — DBIL
- K981978 — AUTOLDL CHOLESTEROL REAGENT SET AND AUTOLDL CHOLESTEROL CALIBRATOR
- K982007 — TRUBYTE DENTURE BOND DENTURE BONDING AGENT
- K982094 — VERABOND 2
- K982277 — MODIFICATION TO STAT PROFILE PHOX BLOOD GAS ANALYZER (K980991)
- K982290 — CHEM-CHEX STAT (NEW)
- K970712 — LAPARO-TENSER
- K971084 — MODEL 02 OXYGEN ANALYZER
- K974200 — ORCA CARDIOPULMONARY EXERCISE TESTING SYSTEM
- K980290 — ITI STENT
- K980517 — EPILASER NORMAL MODE RUBY LASER
- K982047 — MPS HUBER NEEDLE EXTENSION SET
- K982123 — CONTRAST CONTROL DEVICE
- K982184 — WALLSTENT ENDOPROSTHESIS
- K980302 — WORKING ELEMENTS, RESECTOSCOPE SHEATHS, ELECTRODES, OBTURATORS, ENDOSCOPES
- K980648 — PRO VISION
- K981029 — BINDAZYME ANTI-PR3 ENZYME IMMUNOASSAY KIT
- K981030 — BINDAZYME ANTI-MPO ENZYME IMMUNOASSAY KIT
- K981438 — DORNIER MEDILAS E
- K981637 — INTEGRATED DRIVE/PUMP SYSTEM FOR OTOLARYNGOLOGY
- K982231 — STATUSFLOW
- DEN980003 — DIAMOND PROBE/PERIO 2000 SYSTEM
- K970069 — DUAL HOOK FIBEROPTIC DELIVERY SYSTEM
- K972575 — 800 SERIES SURGICAL LASER SYSTEM ORION SERIES SURGICAL LASER SYSTEM ANGLED DELIVERY DEVICES
- K972846 — BMC RF CANNULA
- K973430 — KODAK PRO-MEDICAL DIGITAL CAMERA SYSTEM
- K980185 — COLORPAC TOXIN A
- K980668 — CMS BLIZZARD 700 SERIES MODELS 730, 740,750,760,770,780 & 790
- K980670 — CMS BLIZZARD 700 SERIES MODELS 710, 711, 712, 720, 721 AND 722
- K980778 — HAKIM MICRO PROGRAMMABLE VALVE SYSTEM
- K981417 — Squirt Fluid Delivery System
- K981424 — NOMOS BAT ULTRASOUND LOCALIZATION AND POSITIONING SYSTEM
- K981463 — OMNITECH RESECTOSCOPE ROLLER ELECTRODE
- K981576 — MULTI-PARAMETER MODULE, MODEL M3000A & DISPLAY UNIT, MODEL M3046A
- K981602 — DEVILBISS MODEL 6305D HEAVY DUTY AC ASPIRATOR
- K981614 — NON-STERILE HOLSTER, STERILE HOLSTER MODEL ESH1-NS, ESH1, ES PENCIL W/ HOLSTER, ES SMOKE & FLUID PENCIL W/ HOLSTER MODEL
- K981641 — MAMMOGRAPHY X-RAY EQUIPMENT MODELS MGF101 AND MGF110, ALPHA III, ALPHA ST, ALPHA RT AND ALPHA IQ
- K981672 — RADIOTHERAPEUTICS RF-2000 RADIOFREQUENCY GENERATOR
- K981716 — EXTERNAL FIXATION
- K981718 — DORNIER MEDILAS H
- K981730 — DIGIT-GRIP WITH LCD, MODEL NUMBER DGR 002
- K981745 — BIOTRANS REUSABLE SENSOR BASE MODEL NUMBER BT XXXXXX
- K981757 — SYNTHES (USA) DHS HELIX SYSTEM
- K981847 — BIOLOX ALUMINA CERAMIC FEMORAL HEAD
- K981891 — AMBU TUBECHECK
- K981967 — WASHERLOC SCREW SYSTEM, LIGAMENT SCREW SYSTEM, NO-PROFILE BI-CORTICAL SCREW SYSTEM, CHANNEL LIGAMENT CLAMP, HECKMAN SCRE
- K982085 — MEDICAL DEVICE TECHNOLOGIES, INC. TRU-CORE DISPOSALE SEMI-AUTOMATIC BIOPDY INSTRUMENT
- K972700 — EXMOOR ATTIC AND MASTOID ANTRUM MIDDLE EAR IMPLANT (EMMETT CAMPBELL MD FACS PATTERN)
- K973004 — KNIGHTSTAR 335
- K980066 — CPR FILTERSHIELD
- K980879 — OSCILLOMATE NIBP / SP02 EMS MONITOR
- K980920 — EQUINOXE
- K981405 — SYNERGY LT
- K981406 — CERVIX COIL LATEX SHEATH
- K981414 — LC POSITIONER
- K972538 — FLOW-EZE BLUNT CANNULA (1999BC)
- K972728 — STERILE WATER FOR INJECTION PREFILLED SYRING (SWFIPS)
- K974586 — AURORA DIODE LASER SYSTEM
- K974736 — HEARTPORT DIRECT AORTIC RETURN CANNULA WITH INTRODUCER
- K981235 — OCULOSTAT
- K981381 — ACS HI-TORQUE CROSS-IT GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING PRODUCT FAMILY MODELS 1003211H,1003212HJ,1003213H,1
- K981533 — AVIVA SYSTEMS MODEL NUMBERS 1010, 2020
- K981546 — NTI CLENCHING SUPPRESSION SYSTEM
- K981575 — TYMPANOSTOMY TUBE
- K981619 — VACUETTE MULTIPLE SAMPLE LUER ADAPTER
- K974040 — C3 EXTERNAL MALE BLADDER CONTROL DEVICE
- K974457 — SCOUT 3.2/45 MHZ CORONARY IMAGING CATHETER, SCOUT 3.2/45 MHZ CORONARY IMAGING CATHETER, SCOUT IMAGING CATHETER PATIENT T
- K974730 — SOFTRANS PLUS INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 5000, SOFTRANS PLUS IUPC)
- K981266 — AUTO-INJECTOR, SURE-INJECT 2000
- K981391 — PAR-ONE
- K981415 — 0-20 CM H20 PEEP VALVE
- K981459 — MEMBRANE TACK
- K981466 — XR-910
Data sourced from openFDA. This site is unofficial and independent of the FDA.