FDA 510(k) clearances — page 899
clearances on record, most recent first.
Clearances — page 899
89,801–89,900 of 176,637- K982800 — ECTON LYNX ULTRASOUND SYSTEM
- K982802 — BAYER ADVIA 60 HEMATOLOGY SYSTEM (IN VITRO DIAGNOSTIC SYSTEM)
- K982869 — ASCENT SYSTEM
- K982922 — VACUTAINER BRAND BLOOD COLLECTION SYRINGE
- K982945 — DUAL PURPOSE CLOSED CATHETER
- K983017 — MODIFICATION TO SYSTEM 83 PLUS
- K983088 — INSTACINE D-2000
- K983114 — MAGNATEK80
- K983166 — ELECSYS CALCHECK MYOGLOBIN
- K981163 — DIAMEDIX IS-CMV IGG TEST SYSTEM
- K981682 — UPRO
- K982152 — QUICK SCREEN BARBITURATE SCREENING TEST MODELS 9020 AND 9021, QUICK SCREEN PRO MULTI DRUG SCREENING TEST MODL 9152
- K982394 — PRIME & BOND NT DUAL CURE UNIVERSAL DENTAL ADHESIVE SYSTEM
- K982767 — RAICHEM HDL-CHOLESTEROL DIRECT REAGENT, HDL-CHOLESTEROL CALIBRATOR
- K980816 — RETINAL DETACHMENT IMPLANTS, INCLUDING BANDS, STRIPS (RAILS) AND SPONGES
- K981297 — IMMULITE OM-MA, MODELS LKOPZ, LKOP1, LKOP5
- K982176 — KIRWAN SURGICAL PRODUCTS, INC. MODEL 28 1500 ELECTROSURGERY GENERATOR
- K982182 — FEMOSTOP II PLUS DISPOSABLE SET MODEL 11166, FEMOSTOP II PLUS COMPRESSION ARCH MODEL 11168, FEMOSTOP II BILATERAL ADAPT0
- K982215 — MANUAL RESUSCITATOR WITH ACE
- K982294 — XOMED SILICONE PRE-FORM BLOCKS
- K982496 — QUADRATURE LOWER EXTREMITY COIL, MODEL # 473SI-42D
- K982846 — MTEK-1400
- K973448 — ACCESS TOXOPLASMA IGM REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 34460, 34465, 34469
- K981726 — PERCUSSIVETECH HF, MODEL 2001
- K982121 — ENZYMATIC MITOCHONDRIAL ANTIBODY (M2) REAGENT
- K982171 — HAMAMATSU PET SCANNER, MODEL SHR-22000
- K982179 — TRUMIST AIR ENTRAINED DISPOSABLE NEBULIZER
- K982405 — MTEK-1000
- K983003 — 1 MASS TRANSIT INFUSION CATHETER, 1 VARIOUS
- K973076 — EUROMEDICAL HAEMATURIA FOLEY CATHETER
- K974399 — BIO-OSS COLLAGEN
- K982105 — ORAL POTENTIAL METER (OPM)
- K982187 — FAST-CATH INTRA-CARDIAC INTRODUCER
- K982507 — MINI POLYURETHANE CATHETER
- K983133 — TBIL
- K970321 — BIO-OSS ANORGANIC BOVINE BONE
- K970700 — FRESENIUS POLYSULFONE HEMODIALYZERS, BOTH LOW AND HIGH FLUX
- K981144 — CLEAN SOURCE I, MODEL CS1000
- K981563 — BIOPAK MEASUREMENT SYSTEM
- K981573 — UBI MAGIWEL PAP (PROSTATIC ACID PHOSPHATASE) EIA QUANTITATVE
- K981661 — HEMAPROMPT
- K982111 — VARIOUS DENTAL IMPLANTS
- K982135 — OSCILLOMATE EMS NIBP MONITOR MODEL 9001
- K982139 — BIOSORBFX 1.5/2.0 BIOABSORBABLE FIXATION SYSTEM
- K982318 — SPECTRUM 800 CURING UNIT
- K982343 — ALLERGEN IMMUNOCAP MODELS D73, D74, E71, E72, E73, E74 E75, E76,E82,E88, F48, F90, F92, F96, F201, F215, M70, T17, T72,3
- K982480 — PERIOVIEW MODEL DV-1 FIBERSCOPE AND WINDOW SHEATH.
- K982539 — HDLC PRECIPITATING REAGENT
- K982729 — RENEW
- K972382 — UB ANALYZER UA-2, REAGENT KIT AND BILIRUBIN CONTROL
- K980566 — VAXESS PERIPHERALLY INSERTED CENTRAL CATHETER
- K980662 — LICHEN, BACTERIAL IN LINE BREATHING FILTER
- K981143 — DILKES LASER/SUCTION CANNULAE
- K981570 — AARON 1200 HIGH FREQUENCY ELECTROSURGICAL GENERATOR, MODEL A1200 AARON 1200 HIGH FREQUENCY ELECTROSURGICAL GENERATOR MOD
- K982146 — PICTOOLS MEDICAL TOOL KIT MODEL 1.0
- K982169 — SHERLOCK THREADED SUTURE ANCHOR (TIN COATED)
- K982191 — CHEMICAL CURE COMPOSITE WITH ENAMEL BOND
- K982320 — DEPUY MOTECH MOSS MIAMI SPINAL SYSTEM
- K982388 — SURGI STIM
- K982390 — CONCISE COMPRESSION HIP SCREW SYSTEM (STERILE)
- K982396 — VISIVOX, MODEL V-2
- K982408 — AEROTEE, MODEL # 1001
- K982462 — FIBER OPTIC ENDOILLUMINATION PROBE
- K982483 — DEPUY MOTECH PEAK FIXATION SYSTEM
- K982511 — DEPUY MOTECH MOSS MIAMI SPINAL SYSTEMS
- K982601 — OSTEO IC RETROGRADE/ANTEGRADE FEMORAL NAIL
- K982602 — RETROGRADE ROD SYSTEM
- K982629 — DORNIER MEDILAS D
- K982742 — DISPOSABLE HAND SWITCHING PENCIL, ROCKER SWITCH, ONE PIECE AND ONE PIECE HOLSTER MODELS SB 313 RS, SB 313 RSH
- K982743 — DISPOSABLE HAND SWITCHING PENCIL, PUSH BUTTON WITH AND WITHOUT HOLSTER, MODEL #'S SB 313 PB, SB 313 PBH
- K982746 — MONOPOLAR SUCTION COAGULATOR, MODEL # SB 110-1
- K982749 — MONOPOLAR FOOT CONTROL PENCIL, MODEL # SB 112-2
- K982827 — DERMA K ER:YAG/CO2 LASER
- K982884 — DISPOSABLE HAND SWITCHING PENCIL, ROCKER SWITCH TWO PIECE, SB 312RS, TWO DISPOSABLE HAND SWITCHING PENCIL, ROCKER SWITCH
- K983019 — CARBON DIOXIDE-SL ASSAY, CAT # 253-01
- K983127 — OPIATES 2000 LIQUID OPIATES DRUGS OF ABUSE CONTROL LEVELS G2 AND G3
- K980578 — INNERDYNE RADIALLY EXPANDING VASCULAR ACCESS SYSTEM (HEPARIN COATED)
- K980696 — FOAM TIP INJECTOR
- K980908 — LACTATE PRO SYSTEM
- K982083 — ACS HI-TORQUE BALANCE HEAVYWEIGHT GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING
- K982103 — ULMER (VNG) VIDEO NYSTAGMOGRAPH
- K982216 — ULTIMA RESPIRATORY EFFORT SENSOR MODELS 0520 AND 0522
- K982331 — KELLER PULSE OXIMETER, MODEL 850+
- K982529 — RANDOX DIRECT LDL CHOLESTEROL
- K982744 — DISPOSABLE HAND SWITCHING PENCIL, PUSH BUTTON, 2 PIECE WITH AND WITHOUT HOLSTER, MODELS SB 312PB, SB 312 PBH
- K982894 — MIC-KEY GLOW PROFILE GASTROSTOMY REPLACEMENT KIT
- K974188 — CETYLCIDE-G
- K980869 — SYNOX SX 53-BP, SX 60-BP, SX 45-JBP, SX 53-JBP , MODELS 120 444, 119 684, 120 438 AND 120 143
- K981334 — LAPARO CO2-PNEU (AND WITH VIDEO MONITORING)
- K981344 — URESIL PERCUTANEOUS DRAINAGE CATHETERS WITH HYDROPHILIC COATING
- K982120 — DIGITAL IMAGING SYSTEM, MODELS DIGITREX-1000 AND DIGITREX-2000 (DIGITREX-X000 FAMILY)
- K982149 — SMITH & NEPHEW DYONICS MICROLAPAROSCOPE
- K982223 — CAPIOX SX HARDSHELL RESEVOIR
- K982254 — COBE SENTRY SMARXT 43 MICRON ARTERIAL FILTER WITH PRIMEGARD
- K982397 — VES 3001-M COMPLETE VIDEO ENDOSCOPIC SYSTEM
- K982557 — BARD PROFORMA AND APOLLO PRE-CURVED PAPILLOTOMES
- K982589 — SURGEON'S GLOVE
- K982702 — VENTRIX SUBDURAL TUNNELING PRESSURE MONITORING KIT MODEL NL950-SD
- K983034 — CYNOSURE CO3 ER:YAG LASER
- K980429 — HP M2600A VIRIDIA TELEMETRY SYSTEM (FORMERLY KNOWN AS THE HP 2600A OMNI-CARE TELEMETRY SYSTEM)
Data sourced from openFDA. This site is unofficial and independent of the FDA.