FDA 510(k) clearances — page 426
clearances on record, most recent first.
Clearances — page 426
42,501–42,600 of 175,770- K122242 — ELECSYS CA 15-3 II CALCHECK 5
- K122248 — IGROW II HAIR GROWTH SYSTEM
- K122605 — PKS BILL
- K122630 — IN:C2 SPINAL FIXATION SYSTEM
- K122645 — MOBILE CAREGUIDE 2100 OXIMETER
- K122745 — ZIMMER PERSONA THE PERSONALIZED KNEE SYSTEM
- K122759 — OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY CARDOXY-THC (THCA)
- K123137 — CALYPSO SYSTEM
- K123197 — VERIGENE C. DIFFICILE NUCLEIC ACID TEST (CDF)
- K123226 — LESSRAY
- K123622 — ACUSON
- K120995 — ERAD PACS/ERAD RIS/PACS/ERAD EPVLITE VIEWER SOFTWARE PRODUCT
- K122660 — RESOLUTION CLIP MODEL M00522600, M00522601, M00522602, M00522610, M00522611, M00522612
- K122692 — ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM, NON-POROUS HUMERAL STEMS
- K122814 — GALLEON PEDICLE SCREW SYSTEM
- K122829 — LENSAR LASER SYSTEM - FS 3D FOR CORNEAL INCISIONS
- K122901 — FIREBIRD SPINAL FIXATION SYSTEM, PHOENIX MIS SPINAL FIXATION SYSTEM
- K123031 — BWF-5 MEDICAL LASER SERIES
- K123451 — POLARIS SPINAL SYSTEM - BALLISTA II RODS
- K123463 — INTUITIVE SURGICAL DA VINCI SI SURGICAL SYSTEM SMARTPEDALS
- K103542 — GENSTRIP TEST STRIP MODEL 100-201
- K121321 — HARD SHELL VENTED NASAL MASK
- K121361 — CURALINE POLYURETHANE FOAM AWC DRESSING
- K121559 — HYLATOPICPLUS LOTION
- K121936 — NAVIOPFS
- K121994 — DIMENSION VISTA VITAMIN B12 (VB12) FLEX REAGENT CARTRIDGE, DIMENSION VISTA LOCI 4 CALIBRATOR
- K122326 — SMARTTOOLS KNEE SYSTEM
- K122419 — UCP HOME DRUG SCREENING TEST CUPS
- K122762 — ACCULIS ACCU21 PMTA MICROWAVE TISSUE ABLATION APPLICATOR
- K122893 — POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR(NON-COLORED)
- K122920 — POWDER FREE VINYL PATIENT EXAMINATION GLOVES, COLORED (YELLOW)
- K122999 — POWDER FREE NITRILE EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS
- K123377 — TARGET DETACHABLE COIL
- K123378 — SOLITAIRE 2 REVASCULARIZATION DEVICE
- K121501 — ARROW JUGULAR AXILLO-SUBCLAVIAN CENTRAL CATHETER (JACC)
- K121566 — PLANER BT37 INCUBATOR
- K121649 — CONSTRUX MINI PEEK TI SPACER SYSTEM
- K121847 — TITAN
- K121927 — MICROSTREAM FILTERLINE ICU
- K121995 — TS FIXTURE SYSTEM
- K122722 — COBAS C TINA-QUANT LIPOPROTEIN (A) GEN 2 ASSAY MODEL 05852625190; PRECISET LP (A) GEN 2 CALIFRATOR SET MODEL 05852641160
- K123037 — LIGHTSCALPEL
- K123080 — CHEMTRUE SINGLE/MULTI-PANEL DRUG SCREEN DIP CARD/ CASSETTE TESTS
- K123207 — PRIMALIF TM LLIF UNITARY PEEK LATERAL LUMBAR INTERBODY FUSION SYSTEM
- K121475 — TXCELL SCANNING LASER DELIVERY SYSTEM
- K121775 — ENFLOW IV FLUID WARMER, ENFLOW DISPOSABLE CARTRIDGE, ENFLOW CONTROLLER
- K122052 — MINIFIX BALL MINIFIX ONE
- K122161 — SJM CONFIRM
- K122334 — CHECKMATE SMALL BONE FUSION SYSTEM
- K122420 — DIAZYME 25-HYDROXY VITAMIN D EIA KIT DIAZYME 25-HYDROXY VITAMIN D EIA CONTROL SET DIA
- K122429 — VESSEL ANALYSIS AND AUTOPLAQUE FOR ORS VISUAL
- K122495 — PERKINELMER XRD 1622 AP3 MED FLAT PANEL DETECTOR
- K122543 — AZUR PURE PERIPHERAL COIL SYSTEM, PUSHABLE 18 AZUR PURE PERIPHERAL COIL SYSTEM, PUSHABLE 35
- K123020 — BLIP MODEL BP-700WF
- K123035 — SEAL ONE
- K123119 — CERARESIN BOND
- K123218 — ILLICO FS FACET FIXATION SYSTEM
- K123384 — AZUR CX DETACHABLE 18
- K120651 — STABILIZ FIXATION SYSTEM
- K120787 — MERETE LOCKING BONE PLATE SYSTEM III
- K120862 — WATER BOTTLE CAP IRRIGATON SYSTEM
- K121093 — D1 LED CURING LIGHT, SPEC 3, DENTRONIX LED 3000
- K121346 — PICOSURE WORKSTATION
- K121763 — MULTICROSS SUPPORT CATHETER
- K121989 — OPTECURE BONE VOID FILLER (0.5 CC, 1CC, 2CC, 5CC, 10CC, AND 20CC), OPTECURE + CCC BONE VOID FILLER (1CC, 2CC, 5CC, 10CC,
- K122561 — ADAPTAIN FASTWRAP, ENVELOCK, GRAFTAIN
- K122725 — TANDA PEARL, ULTRAWYTE, PEARL
- K123379 — ABBOTT ARCHITECT FREE T4
- K112462 — KITAZATO OPU NEEDLE
- K120409 — PICCOLO COMPOSITE PLATE SYSTEM
- K120904 — POLARIS DIAL-A-DATE CONTACT LENS CASE
- K121171 — CUROS TIP
- K121816 — SENSUS ELECTRODE
- K121363 — DIOWAVE LOW LEVEL COLD LASER SYSTEM
- K121874 — G7 ACETABULAR SYSTEM
- K120217 — SONICSTIMU COMBO THERAPEUTIC DEVICE
- K120326 — AQT90 FLEX CKMB TEST KIT, AQT90 FLEX LQC MULTI-CHECK, LEVELS 1-3, AQT90 FLEX CKMB CAL CARTRIDGE
- K121216 — STR GRAFT
- K121662 — VECTTOR VT-200
- K121811 — POWDER FREE STERILE LATEX EXAM RADIATION ATTENUATION GLOVES
- K121953 — HEMASORB APPLY
- K121963 — PLANMED NUANCE DIGIGUIDE
- K122110 — ACON ON CALL VIVID PAL BLOOD GLUCOSE MONITORING SYSTEM
- K122154 — POWERPLAY MUSCLE MASSAGER
- K122305 — CORIN TRINITY-I ACETABULAR SHELL
- K122581 — MODIFIED BALLOON GUIDE CATHETER MODEL 90253, 90254
- K123015 — .DECIMAL PHOTON BLOCK
- DEN100023 — AHIP INTERNAL TRIGGER POINT WAND MODEL: 1
- K113315 — RUMBLE TUFF
- K121085 — HET BIPOLAR LIGATOR SYSTEM
- K121220 — EQUINOXE GLENOID, UHMWPE 16 PS=OSTERIOR AUGMENT PEGGED, SMALL, LEFT/RIGHT
- K121234 — GORE(R) DRYSEAL SHEATH WITH HYDROPHILIC COATING
- K121365 — THERMOFORMED MOUTHGUARDS
- K121499 — FUJIFILM TOMOSYNTHESIS OPTION FOR FDR ACSELERATE STATIONARY X-RAY SYSTEM
- K121546 — VITEK 2 GRAM NEGATIVE DOXYCYCLINE
- K121603 — RANDOX IMMUNOASSAY SPECIALITY CONTROL (II), LEVEL 1, LEVEL 2 AND LEVEL 3
- K121712 — AIRSTRIP RPM FOR LIFENET CONSULT
- K121757 — HEALTHMATEFOREVER
- K121846 — CONTIPLEX C CONTINUOUS PERIPHERAL NERVE BLOCK NEEDLE
- K121865 — ZOLL RESCUENET 12-LEAD
Data sourced from openFDA. This site is unofficial and independent of the FDA.