FDA 510(k) clearances — page 963
clearances on record, most recent first.
Clearances — page 963
96,201–96,300 of 176,637- K965111 — STABILIZER SOFT TISSUE ANCHOR MODEL NUMBER TA1005, TA1008, ANCHOR INSERTER/SUTURE ORGANIZER MODEL NUMBERS AI1005, AI1008
- K965134 — ALT/SGPT
- K965250 — SAS SERUM/URINE HCG
- K965253 — SAS PREGNANCY STRIP
- K970008 — ADVANCED QUALITY PREGNANCY TEST
- K970066 — UNIMED COATED LAPAROSCOPIC/ARTHROSCOPY/SUCTION-IRRIGATION ELECTRODE
- K970389 — THYROID CALIBRATOR
- K941604 — VENTANA ANTI-CD4 PRIMARY ANTIBODY
- K941784 — VENTANA ANTI-CD8 PRIMARY ANTIBODY
- K960640 — S*E*M*M* SET FOR MOTO DRIVE WISAP #7689 SSM (MODIFICATION)
- K960727 — EVENFLO NATURAL MOTHER ELECTRIC BREAST PUMP KIT
- K961246 — SJM SEGUIN ANNULOPLASTY RING MODEL SAR-M
- K961252 — DSXL DIFFUSION SPIROMETER
- K963131 — GRASEBY ANDERSEN'S, INTEGRITY S700
- K963441 — BALDUR VINYL POWDERED GLOVES
- K963505 — TENET MLTI-POSITIONING SURGICAL STIRRUP SYSTEM
- K963981 — VYGON BIONECTOR WITH EXTENSION SET
- K964171 — VASOVIEW BALLOON DISSECTION SYSTEM
- K964358 — AMSEAL SURGICAL FACE MASK
- K964543 — INFRASONICS ADULT VENTILATOR TRENDING OPTION
- K964598 — TRUSTEX COLA FLAVORD CONDOM
- K964599 — TRUSTEX CHOCOLATE FLAVORED CONDOM IN BLACK COLOR
- K964653 — OASIS HUMIDIFIER
- K964658 — OASIS
- K964684 — SOFTOUCH
- K964765 — CHIRON DIAGNOSTICS ACS: 180 CARBAMAZEPINE ASSAY
- K964800 — JIAWANG PRE-POWDERED VINYL EXAMINATION GLOVES
- K964827 — PROD. NO. 01-132 - SUTURE REMOVAL KIT
- K964955 — FLEXFINDER GUIDEWIRE (REGULAR SHAFT/STIFF SHAFT) MARKED INK BANDS ENCAP+/GUIDEWIRE(REGULAR SHAFT/STIFF SHAFT) NO MARKING
- K965086 — CYGNUS ELECTROSURGICAL TIP CLEANER
- K965138 — DENTINSENSE B/C
- K965201 — O.R. SCRUB PREP TRAY, STERILE, DISPOSABLE
- K965248 — BEMIS TWO GALLON SHARPS CONTAINER
- K970085 — SEALITE SCIENCES AQUALITE FSH
- K970186 — GI SUPPLY PARACENTESIS PUMP
- K970187 — RUNYON LARGE VOLUME PARACENTESIS KIT
- K970225 — ALPHA MICRON 20/40 MICROAGGREGATE FILTER
- K970311 — BENTLEY MANUALLY OPERATED WHEELCHAIR
- K970343 — MMB METHOD
- K963045 — SYNTHES (U.S.A.) UNIVERSAL SACRAL SYSTEM
- K963148 — NEXGEN COMPLETE KNEE SOLUTION
- K963285 — EMS SWISS LITHOCLAST LITHOTRIPTER
- K963466 — PEDIATRIC LIMB HOLDER
- K963729 — SD-610M(ALSO KNOWN AS STANDARD TENS, SD-609M,SD-611M, GLC-I STANDARD)
- K963940 — EXETER MESH
- K964079 — SPEEDBAND MULTIPLE BAND LIGATOR
- K964591 — TRUSTEX GRAPE FLAVORED CONDOM IN PURPLE COLOR
- K964769 — VERSYS HIP SYSTEM--FIBER METAL TAPER HIP PROSTHESIS
- K964953 — IN-TAC BONE ANCHOR SYSTEM
- K962717 — 6 FRENCH, 7 FRENCH, AND 8 FRENCH GUIDING CATHETERS WITH PHOSPHORYLCHOLINE (PC) POLYMER COATING
- K963004 — BIONECT CREAM
- K963100 — TRONZO ACETABULAR FIXATION COMPONENT (1 99-02-00XX (ACE. FIXATION CUP) XX=OD OF ACE. CUP
- K963101 — B-P HEMISPHERICAL ACETABULAR COMPONENT
- K963115 — TROCAR CANNULA
- K963326 — BREATHE FIT
- K963683 — TRU-PULSE LASER (MODIFIED)
- K963700 — METAGEN HIGH TIBIAL OSTEOTOMY SYSTEM
- K963808 — CHOICE POWERED WHEELCHAIR
- K964783 — EPIDURAL MINI KIT, ELDOR COMBINED SPINAL/EPIDURAL KIT
- K964846 — IMPLATECH RP MEDICAL GRADE SILICONE GEL SHEETING
- K965069 — ANSPACH SUTURE ANCHOR
- K965162 — LUKENS PGA, (POLYGLYCOLIC ACID) SYNTHETIC ABSORBABLE SURGICAL SUTURE,COATED, BRAIDED-U.S.P.
- K970365 — PASSY-MUIR O2 ADAPTER; PMA2000
- K935706 — EPI 2
- K945290 — 8500A PULSE OXIMETER
- K955183 — SAFE KNIGHTS
- K955543 — ULTRASOUND SYSTEM MODEL UF-3500
- K960817 — HD01-SERIES TRANSONIC HEMODIALYSIS MONITOR (R%,QA,CO,QB,QB2)
- K963727 — HOFFMAN H/A COATED LONG-TERM VENTILATION TUBE WITH LINER
- K963945 — STERI-OSS GOLD ATTACHMENT SYSTEM
- K964009 — IMMAGE IMMUNOCHEMISTRY SYSTEM GENTAMICIN(GEN)/TOBRAMYCIN(TOB) REAGENT / BECKMAN DRUG CLAIBRATOR 3 PLUS
- K964369 — TRACH CARE SET WITH MICROBAN
- K964461 — ONE -STEP URINE/SERUM COMBO PREGNANCY CARD TEST
- K964462 — ONE-STEP URINE/SERUM COMNO PREGNANCY DIPSTICK TEST
- K964536 — ONE-STEP DIPSTICK PREGNANCY TEST
- K964544 — OSTEONICS SPINAL SYSTEM - VARIABLE OFFSET CONNECTOR ASSEMBLY
- K964561 — ENDOLUMINA II TRANSILLUMINATION SYSTEM 56FR E-5630, 50FR E-5030 AND 40FR E-4020, ENDOLUMINA II DETACHABLE TIPS, 56FR, TA
- K964657 — SUPER K-AMP, EZ-COMPRESSION, TRIM-PRO, HF-PRO, ENVIRO-PRO, COMPRESSION-PRO, COMPRESSION 3000, HF 3000, OCTIVA, REFLEX HF
- K964678 — PHASED ARRAY NECK COIL
- K964697 — AMD HOME HEALTH MONITOR SYSTEM AND AMD MONITORING STATION
- K964740 — THE NOMOS MINICRANE
- K964753 — MATRIX 3000 FLEXIBLE SPINE COIL
- K964803 — UNIVISION ECHOCARDIOLOGY SYSTEM
- K964840 — BEAM BLOCK TRAYS
- K964854 — MEDRAD PHASED ARRAY 1.5T SHOULDER IMAGING SURGACE COIL
- K964858 — BEMIS TWO GALLON CHEMOTHERAPY CONTAINER
- K970248 — CANTROL SERUM IRON AND TOTAL IRON BINDING CAPACITY TEST SYSTEM
- K941397 — ANTI-VIMENTIN PRIMARY ANTIBODY
- K941516 — VENTANNA ANTI-DESMIN PRIMARY ANTIBODY
- K946279 — PRISMA CFM (CONTINUOUS FLUID MANAGEMENT SYSTEM)
- K961321 — GAMMA GUIDANCE SYSTEM
- K961552 — CVP POLYURETHANE CATHETER
- K961974 — FG-36UX, ULTRASOUND UPPER GI FIBERSCOPE
- K962084 — OMNICAN SYRINGE
- K962576 — SPLINE X ENDOSSEOUS DENTAL IMPLANT SYSTEM
- K962828 — EVERT-IT
- K962835 — HEARTPORT ENDOVENOUS DRAINAGE CANNULA
- K963730 — PROTEC (1024)
- K963804 — PATIENT EXAMINATION GLOVES : NITRILE EXAMINATION GLOVES
- K963830 — SHARPS CONTAINER MODEL# SC001
Data sourced from openFDA. This site is unofficial and independent of the FDA.