FDA 510(k) clearances — page 1346
clearances on record, most recent first.
Clearances — page 1346
134,501–134,600 of 175,890- K883552 — SCEPTOR PSEUDOMONAS PLUS MIC PANEL CAT.# 80328
- K883553 — SCEPTOR RESISTANT GRAM-NEGATIVE MIC PANEL #80331
- K883554 — SCEPTOR PSEUDOMONAS PLUS MIC/ID PANEL #80329
- K883555 — SCEPTOR RESISTANT GRAM-NEGATIVE MIC/ID #80332
- K883821 — FEF(TM) END-TIDAL CO2 DETECTOR
- K874688 — FLOWTRON AC200/2
- K880474 — AREA (DENTAL CHAIR)
- K880475 — SKEMA (DENTAL UNIT)
- K882167 — IVY COMMANDER, MODEL 600
- K882310 — DUAL-TEMP(TM) COOLING/WARMING UNIT
- K882427 — CARDIAC PACE. OPUS 4000 MODELS 4043/4044/4063/4066
- K882800 — COLTENE PRESIDENT JET REGULAR BODY
- K882871 — CASF DRILL GUIDE DG 170
- K883638 — SAFESITE INJECTION SITE AND BLUNT CANNULA
- K883686 — STERILE EMPTY GLASS VIALS
- K875072 — MODIFIED AMANA ELECTROTHERAPEUTIC SYSTEM
- K881341 — NOVA LITE(TM) SA
- K882094 — GARDS DEODORANT SANITARY NAPKIN
- K882231 — SL SERIES, SL 15, 18, 20 & 25 (MODIFICATION)
- K882525 — SPINAL MICROKNIFE
- K882631 — EMPI MODEL 727,NMS
- K882678 — ITE HEARING AID, SIEMENS MODEL 007, WITH TELOS
- K882740 — ACCESS R-CLONE(TM) ANA/RF SCREENING ASSAY
- K882907 — AMERLITE TSH ASSAY, LAN.0001/2001 240 & 144 KIT
- K882922 — TECHMEDICA MP SYSTEM
- K883001 — QM300 CALIBRATOR D PACK
- K883002 — QM300 PREALBUMIN ANTIBODY PACK
- K883103 — EPICARDIA PC/FC
- K883179 — HIP FRACTURE STEM SYSTEM
- K883240 — AVL MODEL 986 ELECTROLYTE ANALYZER
- K883308 — PARKER BATHING SYSTEM
- K883316 — QUIDEL PREGNANCY TEST CONTROL
- K883378 — VISTA MR 2055 HP SYSTEM
- K883492 — TECHNICON DPA-1 IMMUNOGLOBULIN A
- K883493 — TECHNICON DPA-1 IMMUNOGLOBULIN M
- K883508 — HERA H
- K883509 — HERAEUS DG 63
- K883515 — DU PONT DIMENSION C-REACTIVE PROTEIN METHOD
- K883518 — EVENT MARKER & A SECOND PRESSURE TREND OUTPUT
- K883588 — COMPEED ATHLETIC DRESSING
- K883616 — SPECIFIC ALLERGEN MODULES FOR ALASTAT(TM)
- K883711 — QM300 CALIBRATOR F PACK
- K883712 — QM300 CONTROL F PACK
- K883715 — AXIAL COMPRESSION SCREW
- K882009 — KING KONDOM (CONDOM)
- K882018 — MEDACORD PVL, PERSONAL VASCULAR LABORATORY
- K882867 — CORPAK PERCUTANEOUS ENDOSCOPIC GASTROSTOMY TUBE
- K881488 — HOLTER SCANNER
- K882592 — HEART HUGGER STERNUM SUPPORT HARNESS
- K882594 — THE OMNI-FLOW THERAPIST INFUSION MANAGEMENT SYSTEM
- K882654 — PHYSIOTRON(TM) MICROSURGICAL MOTOR & COOLING SYS.
- K882683 — JOBST EXTREMITY PUMP(R) SYSTEM 7500
- K882761 — TRANSERVICAL ENDOSCOPE (HYSTEROSCOPE)
- K883031 — Q-CATH RM
- K883121 — QUIK-PACE II ELECTRODES
- K875179 — MODIFIED LASERFLO BLOOD PERFUSION MONITOR, BPM403A
- K880360 — MODEL #1551 SWITCH CONTROL INTERFACE UNIT
- K880361 — MODEL #1552 ATTENDANT CONTROL OPTION
- K880362 — MODEL #1553 RECLINER INTERFACE
- K880363 — MODEL #1554 PNEUMATIC SWITCH
- K880364 — MODEL #1555 REMOTE JOYSTICK
- K880365 — MODEL #1556 HEAVY-DUTY JOYSTICK
- K880426 — ELECTROSTIMULATOR MODEL 808
- K881993 — PXI (PERSONAL X-RAY IMAGER) 512
- K882133 — MAMMO M
- K882326 — VARIAN CLINAC 1800S
- K882663 — BARBITURATE ENZYME IMMUNOASSAY KIT
- K882729 — MEVATRON, M 2 CLASS
- K882891 — A.C.I. TRACH TIE
- K883181 — SYNCHRON CX4/CX5 CLINICAL CHEMISTRY ANALYZER REAGE
- K883210 — EMIT (R) HVA NEGATIVE URINE
- K883395 — ALKPHOR(TM) SYSTEM, HUMAN SERUM ALKA PHOS ISOENZY
- K883463 — HOSPITAL BED CLOTHING CRADLE
- K883503 — COULTER VISCOMETER II
- K883702 — EXCELVIEW ILLUMINATOR
- K881297 — BARO-GRAF 24
- K882655 — PROCEDURE PACKS PRESS. MONITOR/ADMINISTRATION LINE
- K882664 — MRL OXIMETER
- K882716 — PROCEDURE PACKS SOLUTION ADMINISTRATION SETS
- K882720 — SCIMED R30 SILICONE ASSIST RESERVOIR
- K882803 — ET HI-FLOW SOFT TIP/ET HI-FLOW/ENHANCED TORQUE ST
- K883016 — POLYSAFE IMPLANT. PACING LEADS W/TINED FIXA. TIP
- K883086 — INTERSEPT*PREBYPASS FILTER
- K883325 — PERFORMED CROWN (STAINLESS STEEL)
- K883558 — VITEK GRAM-NEGATIVE IDENTIFICATION CARD
- K883650 — INSTRUMENTARIUM ULF MR IMAGING SYSTEM VERSION 110
- K883682 — CHANG MEDIUM (ADDITIONAL INDICATIONS)
- K881811 — COBE CENTRYSYSTEM HOLLOW FIBER DIALYZERS
- K881889 — CANON IOL ESTIMATOR KU-1
- K882556 — BECTON DICKINSON PCA INFUSER - SOFTWARE MODIFI.
- K882605 — EURO-MED CLEAR-VUE DISPOSABLE VAGINAL SPECULUM
- K882721 — ITC-ITE TYPE HEAR AID/HEAR-O-INC MDL FAVORITE EAR
- K882821 — VITRABOND LIGHT CURE GLASS IONOMER LINER
- K883099 — SITE MACROBORE PHACO NEEDLE
- K883199 — MODIFICATION TO THE SITE PERISTALTIC MODULE SYSTEM
- K883213 — NIDEK OPEATING MICROSCOPE DELIVERY SYSTEM (OMDS)
- K883255 — KOMET SURGICAL BUR
- K883311 — COUNT-A-DOSE
- K883507 — HERAEUS C SPECIAL
- K883510 — DEGUPAL 4
Data sourced from openFDA. This site is unofficial and independent of the FDA.