FDA 510(k) clearances — page 1340
clearances on record, most recent first.
Clearances — page 1340
133,901–134,000 of 175,890- K883478 — DIAGNOSTIC AUDIOMETER, MODEL MIDIMATE 602
- K883643 — TDK ECG ELECTRODE, MEL-10L
- K883755 — MODIFIED SPECTRAX SX/SXT & PASYS/PASYS ST MODELS
- K883827 — MASKS, VARIOUS TYPES OF SURGICAL MASKS
- K883853 — ETA
- K884033 — BIODYNAMICS MODEL 200 BODY COMPOSITION ANALYZER
- K884215 — MINIX 8340, 8341, 8342 MINIX-ST 8330, 8331
- K884387 — CUSHION FLEX(TM)
- K884448 — BLADEMATE
- K884457 — MODULAR COLLARED HJD TOTAL HIP SYSTEM
- K884512 — BEAVER(R) HANDLE
- K884514 — FORCEPS, TOWEL, BACKHAUS-TSK (BRAND) TOWEL
- K884530 — TRIAD-EP II, PLATE INPUT
- K884558 — IOP ADJUSTABLE STIRRUP
- K872111 — ORTHOTONE
- K875378 — SINGLE PHOTON SET 031 & AZ-701-NTS-SP EMISSION
- K881800 — BCS NO. 1, BODY CARE SYSTEM
- K883038 — P/N 9320 LOW FLOW AIR/OXYGEN MICROBLENDER
- K883236 — CEFAR DUAL
- K883597 — MYODAC
- K883724 — GEMINI FEMORAL HIP PROSTHESIS
- K883854 — DEXSOL
- K883913 — LA MASSEUSE
- K884043 — GRIESHABER MICRO LITE LIGHT PIPE 19 & 20 GAUGE
- K884068 — PULMANEX TM (NEO-NATAL SIZE)
- K884105 — AMERLITE ESTRADIOL ASSAY, LAN.2080 (144 TEST KIT)
- K884123 — AMOS BOY LIFT CHAIR
- K884170 — ANALYST THEOPHYLLINE CALIBRATOR
- K884276 — BECKMAN KAPPA LIGHT CHAIN REAGENT
- K884492 — MICRO SURGICAL INSTRUMENT SYSTEM
- K884496 — RIA/MAT FPA TEST KIT
- K884526 — ADULT RESUSCITATOR WITH MASK AND FILTER
- K881056 — AMRESCO FLOW PAC RANDOM ACCESS LIQUID #4901030
- K882061 — OLYMPUS GF-UM3/EU-M3
- K882464 — DTL MICROTOUCH EYE ELECTRODE
- K883561 — BARD(R) URETERAL STENT W/SUTURE
- K883604 — MEDRAD IMAGE MANAGEMENT SYSTEM (MIMS)
- K883738 — CARBON DIOXIDE LASER SYSTEM MODEL 20-CX W/ATTACH.
- K883926 — .2MM, .4MM, .5MM IRRIGATION AND ASPIRATION HAND.
- K884360 — SEIKO P-6 PROGRESSIVE SPECTACLE LENSES
- K873766 — STERNAL POWER AWL
- K881866 — NEEDLE REMOVER
- K881917 — FLUIDAIR
- K882391 — OPUS 3 PULSE GENERATORS MODELS 4003,4004,4023,4024
- K883120 — FLEX PLASTIC PLASTIC COATED NITINOL ARCH WIRE
- K883667 — DONALDSON VENTILATION TUBES PT. # AG/S9
- K883705 — FACE MASK: COMAS ALSO CHOICE/CONE MASK: POLYMAS
- K883756 — TOSHIBA MRT-50A MAGNETIC RESONANCE SYSTEM
- K883768 — VAS-CATH CATHETER REPAIR KIT
- K883772 — H.A.C. MODEL-A (ALL IN THE EAR)
- K883773 — H.A.C. MODEL-B (ALL IN THE CANAL)
- K883779 — WALLABY(TM) BLANKET
- K884086 — C100 QT VARIABLE HEIGHT ADJUSTMENT INCUBATOR
- K884156 — HYPERBARIC INTRAVENOUS INFUSION EXTENSION SET
- K884264 — HIGH RISK NEEDLE CONNECTOR ASSEMBLY
- K884418 — PREMIER DIE-TRAK ARTICULATOR
- K884553 — STAMEY NEEDLE
- K884584 — TONGUE SEIZING FORCEPS WITH & WITHOUT RUBBER PADS
- K881168 — CREATINE KINASE (CK) ISOENZYME MB
- K881426 — PAN-PRA AID SELF-ADHE. COLLO. COATED BANDAGE
- K882192 — HYGEIA URINE PREGNANCY TEST
- K882570 — TURBOX THEOPHYLLINE ASSAY
- K882923 — KODAK SURECELL CHLAMYDIA TEST KIT
- K883019 — SATURNE 42 AND 43
- K883621 — INSTRUMENTARIUM ULF MR IMAGING SYSTEM
- K883749 — PROBE(TM) MODELS 700 AND 1000
- K883813 — CIBA CORNING BLOOD COLLECTION CAPILLARY TUBE
- K883816 — SHOULDER MICROSTRUCTURED HUMERAL PROSTHESIS
- K883942 — HYCOR SENTRY DRUGS OF ABUSE URINE CONTROL
- K883972 — MAGNESIUM REAGENT (MAGON SULFONATE)
- K884021 — EMDS GLUCOSE (GLUC) TESTPACKS, NO. 67697/95
- K884100 — AMERLITE PROGESTERONE ASSAY, LAN.0079/2079 240/144
- K884108 — MACROPORE MEDICAL/SURGICAL PAPER TAPE
- K884181 — MANUAL SURGICAL INSTRUMENTS (SEVERAL MODELS)
- K884545 — DELFIA (TM) HIGE KIT
- K884548 — LACTATE DEHYDROGENASE TEST (LD) ITEM NO. 65668
- K884549 — ALKALINE PHOSPHATASE TEST (ALP) ITEM NO. 65651
- K881772 — SENSOCOR(TM) R-TEST 240 XL
- K881954 — CONCEPT POWER SYSTEM
- K882254 — OEC-7102 ECG/NIBP MONITOR
- K882635 — ELECTRONIC DIGITAL BLOOD PRESSURE MONITOR
- K883178 — TRIAD-EP, PUSHBUTTON, CABLE INPUT TYPE
- K883215 — KIRSCHNER TC-IV/NON POR COAT/TOTAL CONDYLAR KNEE S
- K883304 — TRAID-EP, PLATE INPUT, W/PULSE BLANKING CIRCUITRY
- K883843 — CARDIOBEEPER II
- K883930 — SEAMED MODEL 3300 DUAL CHAMBER PACING SYSTEM ANALY
- K883973 — MODEL VY-800RA OPTIONAL ACCESSORY TO BSM 8500A
- K884009 — MODEL 459 ELECTROCARDIOCORDER RECORDER
- K884465 — SPIROMETRICS MODEL 2141 SPIRO-FILTER(TM)
- K880723 — DIMENSION WHOLE BLOOD CHOLESTEROL
- K881725 — ENVIROTENT (BED)
- K882715 — STERILE SURGICAL LATEX GLOVES
- K882723 — ALCON FLUID INJECTOR
- K883471 — VKG 1000, VIDEO KERATOMETER
- K883587 — BIOSEARCH 3600 ENTRI FEEDING PUMP
- K884196 — SURGICAL INSTRUMENTS (VARIOUS TYPES & SIZES)
- K884255 — CONCEPT CCT-5200, THERMAL THERAPY SYSTEM
- K884295 — SURGICAL APPAREL, ISOLATION GOWN,MASK,CAP,SLEEVE
- K884373 — KORBER ARTERIOTOMY SCISSORS
- K884380 — BED SHEET, PILLOW CASE
Data sourced from openFDA. This site is unofficial and independent of the FDA.