FDA 510(k) clearances — page 1239
clearances on record, most recent first.
Clearances — page 1239
123,801–123,900 of 175,890- K905324 — WILL-CERAM W-1
- K905326 — MINIGOLD
- K905330 — HARMONY LINE ALLOYS
- K896734 — FEEDING TUBE
- K900924 — WILSON-COOK BALLOON DILATION CATHETERS
- K901597 — INDX DIP S TICKS
- K902178 — YUEFA DISPOSABLE SYRINGE
- K902306 — THE VISONIC DOME(TM)
- K902907 — MAMBA CONDOM (RUBBER LATEX)
- K903132 — ORTHO CHLAMYDIA ANTIGEN ELISA/ELISA CULT EXTRA BUF
- K903145 — HEARSET TELEPHONE HEARING SYSTEM
- K903209 — MAXI-FLOW INSUFFLATOR TUBING SET W/FILTER
- K903559 — HIGH RISK
- K903575 — CHIROFLEX FORCEPS
- K903925 — ARIES MELDICAL MODEL 2100HC HANK CRANK
- K903958 — SEROFAST
- K904196 — MICRO-MIST NEBULIZER
- K904379 — SURGICAL TROCAR AND CANNULA
- K904523 — ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL/MODIFIED
- K904527 — KAPPER
- K904534 — ENEMA BULB
- K904553 — BONE STAPLE(S)
- K904671 — QAR HANDPIECE
- K905012 — STERILE SURGICAL GLOVES/DOUBLE GLOVER
- K905097 — MICRO-AIRE MODEL NUMBER: MK-426
- K905325 — X-L AND X-LX
- K905442 — MRT35-SP
- K905585 — PATIENT EXAM GLOVES(MFG: LIAONING MACHINERY)
- K905621 — ELLIPSE 2.3
- K896047 — THE OMNIFIT EPF HIP JOINT FEMORAL STEM
- K902650 — BODYHEAT
- K903365 — KETOREX SANWA STANDARDS
- K903621 — MAGNUM-20 (TM) INFLATION DEVICE
- K903993 — MICROZYME(TM) METHAMPHET/AMPHET ENZYME IMMUNO KIT
- K904353 — CARDIOMATIC MODEL MSC-2001
- K904376 — ANEROID BLOOD PRESSURE GAUGE
- K904383 — ACUFIT TOTAL HIP
- K904465 — FLEXIBLE ARTHROSCOPE
- K904892 — VACUUM BAKE CYCLE
- K905016 — PEDIATRIC AND INFANT CATH KITS
- K905084 — RAICHEM CREATINE KINASE REAGENT, OPTIMIZED UV
- K905085 — RAICHEM GGT REAGENT
- K905101 — NEONATAL/STERILE/DISPOS/NONINVAS BLOOD PRESS CUFF
- K905510 — LIFEPAK 9 DEFIBRILLATOR & CARDIAC MONITOR/MODIFIED
- K895513 — PERRY SV-1 HYPERBARIC VENTILATOR
- K896098 — GUARDIAN & JANITEX CONDOM/PROPHYLACTIC
- K902754 — ANESTHETIC GAS CALIBRATION MIXTURE
- K902822 — MEDICAL DESIGNS, INC., SPECTRUM II TENS DEVICE
- K902985 — G.E. MST 625/625II/MST 1050/1050II THREE PHASE GEN
- K902988 — G.E. MSI 850/850II/1250 THREE PHASE GENERATORS
- K903761 — CURITY SPINAL ANESTHESIA TRAY
- K903992 — CYGNET CENTRAL
- K904198 — SAFETY NEEDLE SHEATH
- K904342 — SERIES 1990 ARGON SURGICAL LASERS, E1,E6,E14&E20A
- K904354 — LPI MULILASE YAG/532 SURGICAL LASER SYSTEM
- K904610 — HERCULES MODEL 5000 AND 5040 ND:YAG LASER SYSTEMS
- K904614 — GDC-1475
- K905013 — T.C.S. TOTAL CONTACT SEAT
- K905046 — DERMABRADER
- K905126 — COMFORT-AIRE
- K905187 — BONE RASPS
- K905478 — YANKAUER SUCTION DEVICE
- K905515 — ZOETIC GLOVES
- K905550 — PATIENT EXAMINATION GLOVES
- K903156 — CONTROL-TIP CYSTOSCOPIC ELECTRODES
- K903162 — FLEXIBLE ENDOSCOPIC ELECTRODES
- K903421 — TOPCON EC-200 ENDO-PHOTOCOAGULATOR LASER
- K903968 — TOXO-CUBE
- K904022 — NITRO BLUE TETRAZOLIUM REDUCTION
- K904318 — LOCAL REPORT GENERATOR
- K904407 — DISPOSABLE FIBER OPTIC DELIVERY SYST/ND: YAG SURG
- K904609 — XENON LIGHT SOURCE
- K904656 — FLOWERS NASAL IMPLANT
- K904657 — FLOWERS DORSAL COLUMELLA IMPLANT
- K904681 — VLS 5300 300W XENON LIGHT SOURCE
- K904682 — VISTEK ELECTRONIC CONTROLLER
- K904726 — LYTENING TM 6/R
- K904781 — CHOLESTRECH L.D.X (TM) LEVEL 2 CONTROL
- K904784 — CHOLESTECH L.D.X. LEVEL 1 CONTROL
- K904820 — MICROZYME T3 ENZYME IMMUNOASSAY KIT
- K905009 — DIGITCARE I.V. START KIT
- K905099 — ELEGANCE TSH ELISA
- K892671 — WILSON BIOMEDICAL ANGIOGRAPHIC CATHETER
- K900731 — MEDI LISS DENTAL ANALGESIA DEVICE (SBL601)
- K900814 — CATH LAB AUTOMATED INTERACTIVE RECORDER SYSTEMS
- K902404 — SARNS DELPHIN CENTRIFUGAL SYSTEM W/DIRECTION. FLOW
- K902437 — COBE CARDIOTOMY RESERVOIR WITH OR WITHOUT FILTER
- K902631 — COBE ICU CONVERSION KIT
- K902948 — COMFORTRON II (TENS)
- K902969 — SCREW-VENT ENDOSSEOUS HA COATED DENTAL IMPLANTS
- K903037 — LUPO-TEST REAGENT
- K903078 — HASSON STABILIZING ACCESS CANNULA
- K903199 — HOLLOW LUMEN NEEDLE, PART NUMBER: MX920
- K903208 — MAXI-FLOW INSUFFLATOR TUBING SET
- K903284 — YOUNG PROPHY SYSTEM, PS UNIT
- K903481 — ALPHA-FILL, ALPHA-CEM, AND ALPHA-SILVER
- K903491 — MONITRODE
- K903539 — SALTER LABS MODEL #1015
- K903632 — INTERSEPT 1375 VENOUS RESERVOIR
- K903807 — CMV IGM ELISA TEST
Data sourced from openFDA. This site is unofficial and independent of the FDA.