FDA 510(k) clearances — page 988
clearances on record, most recent first.
Clearances — page 988
98,701–98,800 of 176,637- K954156 — STC DIAGNOSTICS AUTO-LYTE URINARY LEUKOCYTE ESTERASE ASSAY
- K954468 — MB/BACT MYCROBACTERIA DETECTION SYSTEM
- K954685 — URITEST - NITRITE IN URINE TEST
- K955360 — INCSTAR CYTOMEGALOVIRUS IGG FAST ELISA ASSAY
- K955361 — INCSTAR CYTOMEGALOVIRUS IGG ELISA ASSAY
- K955451 — CVM TRANSPORT
- K960726 — EVENFLO SOFT-TOUCH ULTRA BATTERY OPERATED BREAST PUMP
- K961278 — COULTER STKS ANALYZER WITH CD4 & CD8 LYMPHOCYTE ANALYSIS
- K961470 — PORT-A-POLE
- K961491 — ELECSYS TSH ASSAY
- K961750 — DOCUMENT CARDIAC ASSAYED CONTROL
- K961762 — REUSABLE ENDOSCOPIC ACCESSORY HANDLE
- K962130 — BRANEMARK SYSTEMS MKII SELK-TAPPING FIXTURE
- K962168 — MUCUS SPECIMEN TRAP
- K962374 — FIBER-SPLINT ML MULTILAYER
- K962416 — DRYTIME FOR BLADDER CONTROL SILENT
- K962573 — ELECSYS PRECICONTROL TSH
- K962574 — WATERS 474 SCANNING FLOURESCENCE DETECTOR (474)
- K962575 — ELECSYS PRECICONTROL CARDIAC
- K962630 — DOCUMENT AMMONIA, ETHANOL, LACTATE ASSAYED CONTROL
- K962694 — OPUS B12 CONTROLS
- K960522 — DIOPEXY PROBE
- K961179 — SENTINEL LIPASE LIQUID MODEL 17.401B
- K961182 — 3D SCOPE
- K961264 — ENDOPATH EZ-RF LINEAR CUTTER AND COAGULATION
- K961615 — LOW PROFILE TITANIUM PORT DETACHED CATHETER SYSTEM CATALOG #1037
- K961652 — LOW PROFILE PLASTIC PORT DETACHED CATHETER SYSTEM CATALOG #1017
- K961727 — NATURAL-HIP SYSTEM - CALCAR REPLACEMENT HIP STEM
- K961880 — MEDCARE SUCTION CONNECTING TUBING
- K961959 — MD TECH BIOPSY SET FOR BONE AND BONE MARROW
- K962070 — YSI 400 SERIES ATUOCLAVABLE REUSABLE TEMPERATURE PROBE
- K962321 — ARTHOCARE ARTHROSCOPIC ELECTROSURGERY SYSTEM MODEL 970
- K953762 — HEART 400 ECG TRANSMITTER
- K955231 — MEDFUSION MODEL 2001 SYRINGE INFUSION PUMP
- K960696 — PERMALUTE COMPOSITE LUTING/RESTORATIVE RESIN SYSTEM
- K960721 — PACEART WRIST ELECTRODES
- K961204 — MUMPS IGG TEST
- K961336 — MEDTRONIC VASCULAR CATHETER, MULTI LUMEN MODELS 84640, 84652
- K961457 — SUBLIMINATOR
- K961502 — LUBRICATING JELLY, LOW VISCOSITY
- K961505 — BEND-A-BEAM HAND CONTROL MALLEABLE ABC HANDPIECE
- K961512 — PERKINS HAND-HELD APPLANATION TONOMETER
- K961583 — A PORT DETACHED CATHETER SYSTEM CATALOG #1002
- K961611 — OLYMPUS BASKET GRASPERS (UROLOGY)
- K961626 — SOLO CPAP SYSTEM
- K961717 — NMI RETROGRADE CARDIOPLEGIA CANNULA-RCCS
- K961720 — CERAMCO CROWNS AND BRIDGES
- K961736 — 17 ANGULATED ABUTMENT
- K961856 — AUTO SUTURE CHEMOSITE TUNNELER
- K961933 — CIRCLE NEPHROSTOMY CATHETER SET
- K962003 — TUAT SPLATTER CONTROL SHIELD SCS-300
- K962065 — 3M VITREBOND LIGHT CURE GLASS IONOMER/BASE
- K962123 — AKROTECH 4000T KINETIC TURNING LOW AIR LOSS SYSTEM
- K962301 — STERNGOLD G-HARD METAL ALLOY
- K962302 — PEGASUS DENTAL ALLOY
- K962303 — STERNGOLD CF
- K962348 — PRIME & BOND 2.1 MULTIPURPOSE DENTIN/ENAMEL BONDING AGENT
- K962365 — XENON LIGHTSOURCE
- K962604 — PROSYS CUSTOM FIT LEG BAG WITH PREATTACHED ADJUSTABLE INLET TUBE FOR PATIENT SIZING
- K954982 — KSEA SCALP BLOOD COLLECTION SET
- K960029 — HYDRASYS AGAROSE GEL ELECTROPHORESIS APPARATUS/HYDRAGEL 15,30 PROTEIN KIT
- K961763 — PULSE*SPRAY INFUSION SYSTEM
- K962308 — EUB-905
- K951541 — IMX RUBELLA IGG
- K952969 — EIDOS 5003 HOLTER SYSTEM
- K960658 — COLLARLESS POLISHED TAPER HIP PROSTHESIS
- K961468 — QUIK-FIL VAPORIZER KEYED FILLER
- K961476 — SALTERLABS 8960 SERIES NEBULIZER (8960/8961/8966/8984)
- K961649 — ACUFEX TIBIAL ANCHOR SCREW & SPIKED WASHER
- K961650 — NICHOLS ADVANTAGE CHEMILUMINESCENCE THYROID STIMULATING HORMONE THIRD GENERATION KIT
- K961701 — MOUSE ANTI-HUMAN CD3, T-CELL, FITC AND CD4, T-CELL, (HELPER/INDUCER) RPE
- K961775 — PROFORE FOUR-LAYER BANDAGE SYSTEM KIT
- K961988 — VALPROIC ACID EIA TEST
- K961997 — USSC BRAIDED SYNTHETIC ABSORBABLE SUTURE
- K962406 — N CRP STANDARD SY
- K962410 — N PROTEIN STANDARD PY
- K946103 — TRUSTEX FLAVOR CONDON IN COLORS
- K951902 — PATHFINDER 700 HOLTER ANALYZER
- K952415 — DUREX, RAMSES, SHEIK
- K954900 — 3M RED DOT ECG LEAD WIRES A
- K955416 — CARDIMAX MODEL FX-2111
- K960725 — MARPP PRESSURE MONITORING SYSTEM
- K961036 — MBI FIBEROPTIC ENDO-ILLUMINATOR
- K961077 — PEP (POSITIVE EXPIRATORY PRESSURE) THERAPY DEVICE
- K961101 — STRYKER CEMENT REMOVAL SYSTEM
- K961118 — MAXIM PF MODELS 033-581/033-590
- K961316 — WOUND HYDROGEL AND/OR STERILE WOUND HYDROGEL
- K961673 — R&D RETIC-PG HEMATOLOGY CONTROL
- K961747 — ARTHROCARE ARTHROSCOPIC ELECTROSURGERY SYSTEM (MODEL 970)
- K961766 — WOUND HYDROGEL & STERILE WOUND HYDROGEL
- K961799 — NATURAL HIP SYSTEM - DRG HIP STEM
- K961846 — NEEDLE CATHETER
- K961926 — SANPOINT MENSTRUAL TAMPON
- K962182 — BURLEW INFANT HOOD
- K962384 — COMFORT SHEATH REUSABLE MALE EXTERNAL CATHETER
- K962413 — COMFORT CATH SPECIAL SELF ADHERING MALE EXTERNAL CATHETER
- K954559 — HOWMEDICCA MODULAR PROXIMAL HUMERUS REPLACEMENT SYSTEM
- K960048 — EZ-PERSONAL PROTECTION KIT WITH SPILL CLEAN UP - PLUS
- K960073 — EZ-PERSONAL PROTECTION KIT WITH SPILL CLEAN UP
- K960258 — NATURAL HIP SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.