FDA 510(k) clearances — page 1630
clearances on record, most recent first.
Clearances — page 1630
162,901–163,000 of 175,890- K812640 — URE SIL EMBOLECTOMY/THROMBECTOMY CATH
- K812641 — URIC ACID REAGENT-ENZYMATIC-COLOR-520 NM
- K812647 — EMIT AUTO CAROUSEL
- K812664 — ACA IMMUNOGLOBULIN G ANALYTICAL TEST
- K812666 — THYROXINE (T4) 125I
- K812669 — SEATTLE II TOTAL HIP SYSTEM
- K812670 — SANDARE FAST 340 PHOSPHORUS PROCEDURE
- K812671 — EMBRITROL CK-MB CONTROLS
- K812677 — UNITEST-POTASSIUM
- K812687 — BRIGHAM II TOTAL HIP SYSTEM
- K812688 — QI 1150-1T INFUSION T
- K812200 — INSUFFLATOR
- K812202 — FIBER OPTIC LIGHT SOURCE
- K812330 — DIALYSATE CONCENTRATE
- K812498 — CLIRANS TE12 HOLLOW FIBER DIALYZER
- K812533 — PLATELET AGITATOR
- K812558 — TISSUE-TEK III ACCU-CUT ROTARY MICROTOME
- K812595 — ULTRA CHEM E-GLU #64976 & 65040
- K812596 — ULTRA ZYME PLUS ALP #64962, 65029 & 30
- K812602 — RABBIT COAGULASE PLASMA
- K812625 — ACA PLASMINOGEN TEST PACK
- K812630 — ACA IMMUNOGLOBULIN G CALIBRATOR
- K812631 — ACA IMMUNOGLOBIN A TEST PACK
- K812632 — ACA IMMUNOGLOBIN M TEST PACK
- K812633 — ACA IMMUNOGLOBULIN A/M CALIBRATORS
- K812648 — EHTOX GASTRIC LAVAGE KIT #2050 & #2070
- K812658 — CEA CONTROL PLASMA
- K812661 — IMMUNOGL. FRACT. OF RABBIT ANTIS./KAPPA
- K812662 — IMMUNOGL. FRACT. OF RABBIT ANTIS./LAMBDA
- K812668 — AFB STAIN SET
- K812685 — ERICKA NEG. PRESSURE ARTERIAL BLOOD LINE
- K812297 — A.D.T. PROCEDURES TRAY
- K812039 — SPIROMETER 210/211
- K812041 — VENTI-MONITOR MODEL 101
- K812144 — CENTERAL MONITOR 360
- K812145 — CARDIORATER CR-3
- K812146 — CARDIORATER CR-5
- K812147 — CARDIORATER CR-7
- K812276 — DISPOSABLE ELECTRODE, #1610
- K812324 — FLOW-DIRECTED THERMODILUTION CATHETER
- K812326 — SORENSON SUBCLAVIAN CATHETER SSC-8
- K812354 — KONTRON PMS 7000
- K812449 — ADAPTIC* C.F.S.
- K812459 — EXMOOR AURAL GROMMET AG/TI
- K812519 — 2000 SERIES PORTABLE RESUSCITATION SYST.
- K812520 — 280/4 MINI-DEFIBRILLATOR
- K812545 — BEAUFILL
- K812546 — BEAUDENT
- K812548 — COBEAU
- K812549 — BEAUSEAL
- K812550 — BEAUCAV
- K812563 — SWAN-GANZ & EDSLAB HEPARIN COATED CATH.
- K812568 — CAVITRON
- K812569 — SHERWOOD WATER TRAP
- K812654 — VELCRO FINGER/TOE SPLINT
- K812655 — VELCRO SPLINT STRAP FASTENERS
- K811706 — LACTIC ACID DIALYSATE ADDITIVE
- K811741 — CELL-CHEX RBC
- K811821 — CAROTID ARTERY CLAMP & TOOLS
- K812012 — TOWNLEY UNICONDYLAR KNEE
- K812045 — INFANT APNEA MONITOR MODEL 100
- K812108 — LOW FIBRINOGEN CONTROL
- K812125 — LAPIN CLEAR CUT II
- K812162 — HEMODIALYSIS TRANSDUCER PROTECTOR
- K812227 — GAMMACOAT (125) INSULIN RADIOIMMUNOASSAY
- K812482 — FOAM WEDGE
- K812503 — BOSCH HEARING INSTRUMENTS
- K812506 — THE ARTHROFILE
- K812540 — CORDIA IM
- K812554 — TOMAC STERILE DISP. LAP SPONGE
- K812574 — HDL CHOLESTEROL REAGENT
- K812583 — BOVINE CHEMISTRY CONTROL I.X. & II.X.
- K812589 — ULTRA CHEM E-TRIG #65024
- K812590 — ULTRA ZYME PLUS LDH #64950, 65038 & 39
- K812591 — ULTRA ZYME PLUS GPT, #64956, 65035 & 36
- K812592 — ULTRA ZYME PLUS GOT #64953, 65033 & 34
- K812621 — DELTA-A.V. FISTULA CANNULATION SET
- K812622 — HEMODIALYSIS VENOUS & ARTERIAL SET
- K801337 — CYBERLITH IX IMPLANTABLE PULSE GENERATOR
- K801339 — TELEMETRY DECODER
- K810500 — BLOOD FREEZING BAG
- K810897 — ALPHA PLASTIC PLASMA BOTTLE
- K811464 — MODEL 535-01 TRACE-A-PACE EKG/TELEMETRY
- K812123 — CYTOMEGELISA TEST KIT
- K812222 — EM-X
- K812249 — SKIN ADHESIVE-50XX
- K812338 — PREZA-PAK II, ARTERIAL BLOOD SAMPLING SY
- K812340 — TITERTEK MICROPLATE INCUBATOR
- K812425 — BECKMAN R.PR CONTROL SERUM SET
- K812427 — CARTMILL/BARRY FEEDING TUBE
- K812429 — DALE COMBO TRACHEOSTOMY TUBE HOLDER
- K812431 — FACTOR VIII DEFICIENT PLASMA #B8D
- K812434 — DIAGNOSTIC KITS & KIT COMPONENTS
- K812451 — CAMPY THIOGLYCOLLATE (TUBE)
- K812453 — SCRIPPSYSTEM IMMUNOGLOBIN RID KIT
- K812454 — PAC-AID
- K812458 — PADAC
- K812486 — IMMUNOGL. FRCT. OF RABBIT ANTISER.-CERUL
- K812487 — IMMUNOGL. FRCT. OF RABBIT ANTISER.-IGM
- K812488 — IMMUNOGL. FRCT. OF RABBIT ANTISER.-IGA
Data sourced from openFDA. This site is unofficial and independent of the FDA.