FDA 510(k) clearances — page 892
clearances on record, most recent first.
Clearances — page 892
89,101–89,200 of 175,890- 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)
- K982517 — CEFPROZIL ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
- K982519 — LEVOFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
- K982520 — CEFONICID ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
- K982523 — SULFISOXAZOLE ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
- K982524 — AMOXICILLIN/CLAVULANIC ACID ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
- K982526 — SPARFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
- K982528 — NAFCILLIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
- K982669 — OXOID STREPTOMYCIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
- K982735 — LIGHT SABER BONE BIOPSY NEEDLE
- K982929 — MAXAIR NASAL DILATOR SYSTEM
- K974352 — CARDIOVIEW 3000 SOFTWARE
- K980457 — ENDO ABSORBABLE INTERFERENCE SCREW
- K981095 — ALIGN SYSTEM
- K982031 — OCULIGHT GL WITH THE DERMATOLOGY HANDPIECE
- K982040 — MEDPOR SURGICAL GRANULE IMPLANTS
- K982042 — ISLAND BIOSURGICAL BLADDER NECK BOLSTR MODEL IBIBOL.002
- K982055 — ACCUPROBE 800 SERIES MODEL NUMBERS : 810, 820, 830, 840, 850, 860, 870 AND 880
- K982116 — AQUACEL HYDROFIBER WOUND DRESSING
- K982234 — AL-GEN CALCIUM ALGINATE DRESSING
- K982258 — MAMMARY SIZER
- K982288 — RADIAL HEAD IMPLANT
- K982401 — PROSTATE BIOPSY NEEDLE
- K982439 — PROXIDERM, MODELS TN 460, TN 90 460, BK 460
- K982445 — MODULAP
- K982494 — BWM SPINE SYSTEM
- K982616 — IPS EMPRESS 2
- K982665 — JUMBO SILVER-REINFORCED GLASS IONOMER
- K982705 — MIDAS TOUCH BIPOLAR FORCEPS
- K982865 — ATRISORB BIOABSORBABLE GUIDED TISSUE REGENERATION (GTR) BARRIER KIT
- K982927 — QUICK TAP SELF DRILLING SCREW
- K973477 — BIOSENSORS EMBOLECTOMY CATHETER
- K980630 — FRIALIT-2 CORABASE
- K980642 — EVITA 4 (8411900)
- K981009 — HEARTPORT ENDOPULMONARY VENT CATHETER
- K981314 — VISUALINE II (ALSO KNOWN AS SUNLINE) METHADONE
- K981999 — ALBATECH PERSONAL MONITOR
- K982014 — STOCKERT COMPACT SYSTEM
- K982023 — PELICALSS HUMAN IGG SUBCLASS NEPHLOMETRIC ARRAY KIT
- K982025 — HEWLETT-PACKARD M2475B WITH 12-LEAD OPTION (#C90) CODEMASTER 100 CONITOR/DEFIBRILLATOR
- K982088 — AFFIRM SMART RELEASABLE FORCE MODULE AND COMPLIANCE SCIENCE SYSTEM
- K982102 — SINGLEDAY INFUSOR 2 ML/HR (ELASTOMERIC INFUSION DEVICE) MODEL, INFUSOR SV 5 ML/HR (ELASTOMERIC INFUSION DEVICE) MODEL CY
- K982117 — FLUID CONTROL
- K982339 — FLOW 7000 PERIPHERAL VASCULAR COIL
- K982595 — NIM4
- K982672 — COLLEAGUE PUMP SYRINGE ADAPTER SET
- K982841 — MODIFICATION TO ALLIGER ULTRASONIC SURGICAL SYSTEM, MODEL AUSS-4
- K982883 — MEDTRONIC 7F AND 8F ZUMA GUIDING CATHETER
Data sourced from openFDA. This site is unofficial and independent of the FDA.