FDA 510(k) clearances — page 871
clearances on record, most recent first.
Clearances — page 871
87,001–87,100 of 176,637- K990705 — MEDAMICUS COAXIAL INTRODUCER KIT, 10330-XXX, BOSTON SCIENTIFIC COAXIAL DILATOR SET
- K990998 — POLYSLIT IFE KIT
- K991000 — GENTLE TOUCH UV (NETRAFILCON A) SOFT CONTACT LENSES
- K991061 — DERMAPHYLYX CALCIUM ALGINATE WOUND DRESSING
- K991234 — THE ACME MEDICAL AESTHETIC ND:YAG LASER
- K991987 — COLOR BUFFED ANSWER CEMENTED FEMORAL
- K983497 — OVERLANDER PEV 2000
- K984343 — PREMIER TYPE SPECIFIC HSV-1 IGG ELISA TEST
- K984346 — PREMIER TYPE SPECIFIC HSV-2 IGG ELISA TEST
- K984508 — SURGICAL CONTRA-ANGLE HANDPIECES, MODELS 975 AE,979 E/KM, 985 AE, 986 AE, 988 E/KM AND SURGICAL STRAIGHT HANDPIECES MOD
- K990122 — INDEPENDENCE 624
- K990484 — INDEPENDENCE 324
- K990771 — 6F HYDROLYSER THROMBECTOMY CATHETER
- K991042 — ASH ADVANTAGE PERITONEAL CATHETER
- K991053 — ASTRA TECH IMPLANTS - DENTAL SYSTEM: NEW FIXTURES (MICROMACRO)
- K991081 — FRAMELESS NEUROMATE
- K991168 — ARROW FWD POWER WHEELCHAIR
- K991257 — FUJI WAVELET COMPRESSION OR FFCOMP IRREVERSIBLE COMPRESSION
- K991325 — MODIFICATION OF ENCORE LINEAR POROUS COATED HIP
- K991366 — DAUM MRI/CONVENTIONAL BIOPSY KIT
- K991444 — HERMES CONTROL CENTER, WITH CONTROL OF THE AESOP 3000HR (HERMES READY).
- K991455 — ORTHOSLICE OS1000 SERIES; PANORAMIC ORTHOSLICE OS 1000: OS1000, OS1000E PANORAMIC AND CEPHALOMETRIC ORTHOSLICE OS1000C,
- K991587 — BLOM-SINGER INDWELLING 2000 VOICE PROSTHESIS
- K991610 — ZEUS SCIENTIFIC INC., TPO IGG ELISA TEST SYSTEM.
- K991704 — N/T PROTEIN CONTROL LC
- K991759 — MAERSK MEDICAL CONTOUR INFUSION SET
- K991793 — ANGIODYNAMICS BALLOON EXPANDABLE BILIARY STENT SYSTEM
- K991843 — GREINER MINICOLLECT LITHIUM HEPARIN GEL BLOOD COLLECTION TUBE
- K991928 — MODULAR LAPAROSCOPIC GRASPING FORCEPS, SCISSORS, NEEDLE HOLDERS & DISSECTORS
- K984116 — HEPA-CARE AIR CLEANER AMERICAN AIR FILTER AIR FILTRATION SYSTEM MODELS HC800F, HFS800F, HC800C/ HFS800C, HC400C/HFS400C
- K990020 — TE ME NA LOSS OF RESISTANCE SYRINGE, 10CC
- K990325 — QUIKSTRIP DIPSCAN X MULTIDRUG SCREENING DEVICE
- K990688 — MTM BIOSCANNER C TEST STRIPS
- K991012 — SIEMENS INFINITY EEG POD
- K991035 — QUANTEC-E IRRIGATION SYSTEM
- K991653 — INVISION-PLUS INJECTION PORT CONNECTOR SYSTEM
- K991689 — LATEX EXAMINATION GLOVES (POWDER FREE)
- K991690 — LATEX EXAMINATION GLOVES (PRE POWDERED)
- K991775 — MODIFICATION TO COMPUTERIZED CATHETERIZATION LABORATORY - HORIZON 9000 WS
- K991784 — RENEW LEAD EXTENSION
- K991891 — CERALAS DIODE LASER SYSTEM, MODEL CERALAS D15
- K981141 — SARGON IMMEDIATE LOAD IMPLANT, MODEL D
- K982467 — CAPIOX CARDIOPLEGIA
- K984298 — Z KAT FLUROTACTIC GUIDANCE SYSTEM MKI
- K990238 — LONGPORT MODEL LDS -1
- K990876 — BRIGHTWAY BRAND BLUE NITRILE EXAMINATION GLOVES (POWDERED)
- K991004 — SYNTHES QUICK LOCK IMF SYSTEM
- K991009 — RC BUTTRESS
- K991011 — ORASCOPE
- K991013 — MINIMED 407C INFUSION PUMP, MODEL 407C
- K991021 — SONIC SCALER WITH FIBER OPTIC, MODEL NAS-L, SONIC SCALER WITHOUT FIBER OPTIC, MODEL NAS-NL
- K991033 — ACTIWATCH-SCORE
- K991037 — EUCLID REDUCTION AND GUIDANCE SYSTEM
- K991064 — METACARPAL FIXATION SYSTEM
- K991142 — CELL-DYN 1200 SYSTEM
- K991171 — DCI ENDOSCOPE
- K991184 — HYDROTONE-THERMAL CAPSULE SYSTEM
- K991190 — DEFLECTABLE ELECTROSURGICAL PROBES
- K991208 — ENDOSCOPIC FIBEROPTIC CABLE
- K991228 — DCI ENDOSCOPE
- K991304 — HEALTH + AID PREMIUM POWDER FREE NITRILE EXAMINATION GLOVES, BLUE
- K991313 — ACCUTRED SHOE
- K991548 — HAL SCOPE HOLDER SYSTEM
- K991564 — JELTEMP
- K991743 — ROYAL SHIELD NON-STERILE BUBBLE GUM SCENTED POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (5O
- K991744 — SMART SHIELD NON-STERILE POWDER-FREE, BLUE NITRILE EXAMINATION GLOVES WITH BUBBLEGUM SCENT
- K991745 — ROYAL SHIELD NON-STERILE POWDER-FREE, GREEN LATEX EXAMINATION GLOVES WITH A PROTEIN CONTENT LABELING CLAIM (50 MICROGRAM
- K991746 — ROYAL SHIELD POWDER-FREE PINEAPPLE SCENTED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR
- K991748 — LAGLOVE BRAND BLUE COLOR LATEX EXAMINATION GLOVE, POWDERED CONTAINING 150 MLGM OR LESSOF WATER EXTRACTABLE PROTEIN PER G
- K991749 — LAGLOVE BRAND BLUE COLOR LATEX EXAMINATION GLOVE, POWDER FREE CONTAINING 50 MLGM OR LESS OF WATER EXTRACTABLE PROTEIN PE
- K991750 — BRIGHTWAY BRAND BLUE COLOR LATEX EXAMINATION GLOVE, POWDER FREE CONTAINING 50 MLGM OR LESS OF WATER EXTRACTABLE PROTEIN
- K991752 — BRIGHTWAY BRAND BLUE COLOR LATEX EXAMINATION GLOVE, POWDERED CONTAINING 150 MLGM OR LESS OF WATER EXTRACTABLE PROTEIN PE
- K991814 — MULTACHOICE INSTRUMENTS
- K991859 — DEXIDE BIPOLAR FORCEPS II ** DEVICE
- K974683 — NAVIPORT DEFLECTABLE TIP GUIDING CATHETER
- K982950 — FINE WIRE ELECTRODE MMODEL NUMBERS 221-14-730, 221-24-730, 221-14-550, 221-24-550
- K983344 — DADE BEHRING QUIKLYTE METABOLYTE CARTRIDGE, MODEL DIMENSION(R) XL OR RXL
- K983373 — IMPACT BALLOON DILATION CATHETER
- K984240 — ENDOPATH ENDOSCOPIC INSTRUMENTS
- K990993 — BIOCHECK SENSITIVE TSH (S-TSH) ENZYME IMMUNOASSAY TEST KIT; CATALOG NUMBER: BC-1003
- K990997 — AKTINA MEDICALPHYSICS CORPORATION MECHANICAL FRONTPOINTER
- K991005 — VENTED DIAKYSATE PORT CCAP, RED PLIABLE VINYL - DAYSPRING MEDICAL PART NO, DPC101VS
- K991056 — WALLSTENT ENTERAL ENDOPROSTHESIS WITH UNISTEP DELIVERY SYSTEM
- K991146 — TSH ENZYME IMMUNOASSAY TEST KIT, MODEL #BC-1001
- K991191 — BONDEK POLYGLYCOLIC ACID SYNTHETIC ABSORBABLE SURGICAL SUTURE
- K991199 — BIOPOTENTIAL SKIN ELECTRODE, MODELS BME 300, BME 200, BME 100, BME 150
- K991248 — PRONTO DRY
- K991440 — ROCHE COBAS INTEGRA SERUM BARBITURATES
- K991443 — ROCHE COBAS INTEGRA SERUM BENZODIAZEPINES (SBENZ)
- K991637 — BARD SPERMA-TEX PRESHAPED MESH (2.4X5.6), MODEL 0114700
- K991912 — MODIFICATION TO DIGIPAN
- K982951 — IMTEC BIOPIN
- K983856 — POWDER FREE VINYL EXAMINATION GLOVES
- K983893 — POWDERED VINYL EXAMINATION GLOVE
- K990138 — DSL ACTIVE AFP ELISA, MODEL DSL-10-8400
- K990186 — SYNTHETIC POWDER-FREE NITRILE PATIENT EXAMINATION GLOVES
- K990644 — QUANTASE TOTAL GALACTOSE SCREENING ASSAY
- K990654 — QUANTASE TOTAL GALACTOSE SCREENING ASSAY 500 TEST KIT
- K991153 — MEDTEXX POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABEL CLAIM (CONTAINS 50 MCGM OR LESS OF TOTAL WATER EXTRACTA\
- K991155 — CHLORINATED POWDER FREE LATEX EXAMINATION GLOVES
Data sourced from openFDA. This site is unofficial and independent of the FDA.