FDA 510(k) clearances — page 980
clearances on record, most recent first.
Clearances — page 980
97,901–98,000 of 175,890- K961876 — AIRIS
- K961900 — TIBIAL TRAY PLUG, A PRODUCT LINE ADDITION TO THE AXIOM TOTAL KNEE SYSTEM
- K961909 — READY-SET PUNCTAL PLUGS
- K962120 — TOMOGRAPH ACCESSORIES
- K962140 — ICT-2000, INTEGRATED C-ARM/TABLE MULTIPURPOSE RADIOGRAPHIC/FLUOROSCOPIC POSITIONING SYSTEM MODEL NO. 6896.300
- K962163 — MISTEN MEDICAL MISTEN MEDICAL SURGICAL DRILL
- K962170 — SIEMENS VITA 160 SERIES POCKET HEARING INSTRUMENT: VITA 162E,166M,168PP
- K962265 — MLX MICROTITER PLATE LUMINOMETER
- K962298 — CENTER OPTICAL GLASSES
- K962337 — ELITYS OR ELITYS-E
- K962382 — XIAMEN CHINGSONG OPTICAL INDUSTRIAL CO., LTD.
- K962419 — CW-DISPOSABLE ACUPUNCTURE NEEDLE
- K962478 — (BRAND NAME) SUNGLASS FRAMES
- K962522 — MODEL SL-YZ5E
- K962532 — RODENSTOCK SLITLAMP (MODEL 5000 & 4000)
- K962636 — SUNGLASSES, GAUDI SUN LINE
- K962688 — MONTGOMERY RADIOPAQUE SALIVARY BYPASS TUBE
- K962725 — SOMA
- K962775 — SUNGLASSES (NON-PRESCRIPTION)
- K951851 — ALLIANCE CYTOMEGALOVIRUS IMMEDIATE EARLY ANTIGEN DIRECT IMMUNOFLUORESCENCE ASSAY
- K954432 — CRYSTAL & CRYSTAL-PLUS IMPLANTS SYSTEM
- K954713 — DURAL-LUMEN INTRA VASCULAR BALLOON CATHETER (MODIFICATION)
- K955362 — INCSTAR HSV I/II IGG FAST ELISA ASSAY
- K955363 — INCSTAR HSZ I/II IGG ELISA ASSAY
- K955414 — XRT 400
- K960083 — MOVABLE CANTILEVERED RADIOGRAPHIC TABLE XRT 100, 200 & 300
- K960176 — DAVOL NASOGASTRIC SUMP TUBE W/PREVENT FILTER
- K960936 — RESPOSABLE TROCAR SYSTEM [5MM, 5MM SHORT, 10MM AND 12MM SIZES]
- K961012 — VZV IGG ELISA TEST SYSTEM
- K961371 — SUBCUTANEOUS URINARY DIVERSON STENT SET
- K962016 — MEDLINE TITANIUM HEMOCLIPS
- K962047 — TITANIUM CANNULATED TIBIAL NAIL (TI CTN)
- K962091 — POLARUS AF ROD
- K962122 — SENTRY RADIOTRANSLUCENT ECG ELECTRODES
- K962324 — STERNGOLD U-CPF METAL ALLOY (1067800)
- K962325 — QUASAR YELLOW CROWN AND BRIDGE ALLOY (1122015)
- K962326 — STERNGOLD BIO-5 (1127210)
- K943503 — CHEMCARD GLUCOSE TEST
- K953875 — CRIT-LINE HEMATOCRIT ALERT (MODIFICATION)
- K954326 — STC DIAGNOSTICS AUTO-LYTE URINARY HEMOGLOBIN ASSAY
- K955815 — G3000 OR AG2000; DISPOSABLE RESTING ELECTRODE
- K960539 — DIAO HAND SURGERY SET
- K960692 — SUBTALAR MBA SYSTEM
- K961577 — PRISM 3000XPV SYSTEM (210714)
- K961586 — URIC ACID-SL ASSAY CATALOGUE NO. 237-60
- K961658 — MEGATRON OPHTHALMIC SURGICAL SYSTEM
- K961824 — COBAS INTEGRA REAGENT CASSETTES FOR ALBUMIN, HBALC AND DIGOXIN
- K962219 — QUICKSTICK ONE STEP PREGNANCY TEST(9010)
- K962304 — STERNGOLD BIO-4
- K962430 — CTM REUSABLE PAK
- K962431 — CTM DISPOSABLE PAK
- K962674 — STA - VWF CONTROL [N]+[P] KIT
- K953813 — LONDON ROYAL CONSUMER PRODUCTS LATEX CONDOMS
- 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
Data sourced from openFDA. This site is unofficial and independent of the FDA.