FDA 510(k) clearances — page 864
clearances on record, most recent first.
Clearances — page 864
86,301–86,400 of 175,890- 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
- K991219 — C-FLEX URETERAL STENTS
- K991305 — HEALTH + AID PREMIUM POWDER FREE LATEX EXAMINATION GLOVES
- K991321 — PACIFIC HEMOSTASIS THROMBOSCREEN 200
- K991362 — HYDRAGEL HEMOGLOBIN(E), MINI HEMOGLOBIN(E), 7 HEMOGLOBIN(E), 15 HEMOGLOBIN(E), ACID(E) HEMOGLOBIN(E), MINI ACID(E) HEMO)
- K991402 — DAKO MOUSE ANTI-HUMAN T-CELL, CD3/RPE-CY5, CLONE UCHT1 & DAKO MOUSE ANTI-HUMAN T-CELL, CD3/RPE, CLONE UCHT1
- K991454 — MOUSE IGG1 NEGATIVE CONTROLS
- K991478 — TENDER TOUCH SILICONE GEL PADS
- K991488 — SELF CURE COMPOSITE
- K991491 — FLC COMPOSITE
- K991513 — HOMEPUMP C-SERIES AND HOMEPUMP C-SERIES ONE-STEP KVO
- K991742 — NON-STERILE, POWDER FREE, POLYMER COATED LATEX EXAMINATION GLOVES WITH WATER EXTRACTABLE PROTEIN CLAIM OF 50 MICROGRAM O
- K982096 — DERMASTIM PLUS, PIGTAILS, FLEXSTIM SUPERFLEX, FLEXSTIM PLUS, CARBONSTIM VERTASTIM, ENDURO
- K990250 — HYDRAGEL LDL/HDL CHOL DIRECT KIT-P.N. 4005, HYDRAGEL 7 LDL/HDL CHOL DIRECT KIT-P.N. 4103, HYDRAGEL LDL/HDL CHOL DIRECT 0
- K990581 — DIRECT HDL-CHOLESTEROL REAGENT
- K990697 — RS-4V MUSCLE STIMULATOR
- K990953 — RENAL LINK
- K990969 — KONICA SRX- 701 AUTOMATIC X-RAY FILM PROCESSOR
- K990996 — GENYX MEDICAL INJECTION NEEDLE
- K991008 — DIMENSION BITE
- K991047 — HARDCOVER CONDOMS MALE LATEX CONDOMS, (WITH SPERMICIDE)
- K991243 — NORMA 10
- K991310 — EXPLOR-X 70
- K991318 — CONVERGENCE NUA FOR HITACHI SPECTRADIGITAL V250DSP GAMMA CAMERAS
- K991518 — PANATOME
- K991671 — HDI 5000 DIAGNOSTIC ULTRASOUND SYSTEM
- K991692 — CHIRON DIAGNOSTICS ACS: 180 FT3
- K991716 — HISPEED NX/I CT SCANNER SYSTEM
- K991751 — STATUS CUP ACCUSIGN CUP
- K983922 — DRIED GRAM-NEGATIVE AND GRAM-POSITIVE MIC/COMBO PANELS
- K990925 — MALE NATURAL RUBBER LATEX CONDOM (WITH LUBRICATION)
- K990930 — 3D ANATOMICAL MESH
- K991179 — ZEUS SCIENTIFIC, INC., THYROGLOBULIN IGG ELISA TEST SYSTEM
- K991526 — ISOSTAR I-125 INTERSTITIAL SEED, MODEL IS-12501
- K991657 — QUANTA LITE ANA ELISA
- K991876 — SEDRITE PLUS ERYTHROCYTE SEDIMENTATION RATE
- K984536 — REMOVABLE CUFF ABUTMENT
- K990944 — OSTEOMED INTRAORAL DISTRACTION SYSTEM
- K991406 — TERUMO SURFLO FLEX I.V. CATHETER AND TERUMO SURFLASH I.V. CATHETER
- K991498 — ACCUWELL TOTAL GALACTOSE, MODEL 6010-EGAL
- K991858 — SSA-390A/POWER VISION 8000
- K991872 — LYNX ULTRASOUND SYSTEM
- K991898 — ULTRA-SELECT GUIDEWIRE, HYTEK GUIDEWIRE
- K990949 — CLEAR-GUARD II, CLEAR-THERM HMEF, CLEAR-THERM HMEF W/ FLEXTUBE, CLEAR GUARD 11 W/ GAS MONITORING PORT
- K991049 — CLIMAX
- K991374 — INVIGRA
- K991376 — DAHEDI INSULIN INFUSION PUMP
- K991425 — XANTOPREN COMFORT
Data sourced from openFDA. This site is unofficial and independent of the FDA.