FDA 510(k) clearances — page 1444
clearances on record, most recent first.
Clearances — page 1444
144,301–144,400 of 175,890- K861953 — PARALLEL ACTION PLIERS
- K861954 — HEXAGONAL WRENCHES
- K854647 — POLO DENTAL UNIT
- K854665 — 4312P POLYSOMNOGRAPH ELECTOENCIPHALOGRAPH
- K854769 — LNI MGV MEDICAL GAS MIXER
- K860051 — MODEL 8604 OXYGEN/PULSE MONITOR
- K860164 — 2500 PRINTER
- K860901 — LASER RESISTANT TRACHEAL TUBE (TENTATIVE)
- K860903 — TM-3600 A NEURODIAGNOSTIC SYSTEM
- K861067 — PARAGON 420, CARDIAC MONITOR
- K861227 — COLLINS PNEUMOTACH PFT SYSTEM
- K861532 — RX-33S INTRA MINI CANAL MODULE
- K861555 — CIRCAPAK UNIVERSAL VOLUME VENTILATOR CIRCUIT
- K861665 — CREATINE PHROSPHOKINASE (CK) PROCEDURE
- K861893 — GGT REAGENT CARTRIDGE (PRODUCT NO. 88204)
- K862042 — SH20, SH30 & SH50 ULTRASONIC HUMIDIFIER
- K862066 — TITERTEK MICROPLATE WASHER S-12
- K862084 — E. T. TAPE ENDOTRACHEAL TUBE HOLDER
- K854686 — TE-25 COAGURO METER
- K854687 — ERMA HB-METER MODEL 303N
- K860609 — TIMELINE VENIPUNCTURE SYSTEM
- K861182 — TIMELINE VENIPUNCTURE SYSTEM
- K861558 — APLICARE SKIN PROTECTANT SWABSTICK
- K861881 — RUBALEX (REVISED VERSION)
- K861969 — STERILE TOWEL W/ANTIMICROBIAL AGENT
- K862016 — PACH-PEN SURGICAL DRAPE
- K861575 — DIRECTATEX STREP A
- K861888 — HIPPURATE HYDROLYSIS TEST
- K861889 — D'ALA RAPID TEST
- K861890 — 100%, 95%, 80% & 70% DEHYDRANT CUSTOM BLEND NO. 2
- K853953 — CARDIOCAP MONITOR
- K854856 — THERMORITE MODEL HC-83 HYPO/HYPERTHERMIA UNIT
- K854903 — GORDON DIAGNOSTIC SYSTEM MODEL I
- K854942 — HORIZON 2000 NON-INVASIVE BLOOD PRESSURE CAP.
- K860121 — INTRAVASCULAR CATHETER W/DOPPLER TRANSDUCER
- K860233 — 5 MHZ INTRACAVITARY PROBE, MODEL H4222V
- K860616 — VOLUME CONTROL SET WITH EXTENSION
- K860956 — KANSAS I/A SYSTEM & KANSAS I/A & VITRECTROMY SYST.
- K860957 — DISPOSABLE ACCESSORIES FOR I/A SYS. & VITEOUS CUT.
- K861091 — EASISTIM
- K861226 — INTERFACE CRYSTALLOID CARDIOPLEGIC FILTER MODEL 70
- K861275 — HIGH FLOW I.V. SET
- K861277 — CRITICHEM CONTINUOUS BLOOD GAS MONTITOR, CVGM-1000
- K861327 — ROHO HEEL PAD
- K861597 — BEHING-THE-EAR HEARING AID SERIES SP
- K861626 — CHURCHILL EXTENSION TUBE
- K861643 — STYLEKEEPER CONTACT LENS CARRYING CASE
- K861683 — MONSANTO SANTOPRENE (PERITONE DEVICE)
- K861748 — RUBY & SAPPHIRE BLADE HOLDER
- K861803 — BRUSHING
- K861921 — LASER BRONCHOSCOPE SYSTEM
- K861986 — LIDO BACK
- K854333 — BIOCHEM 515 RESPIRATION MONITOR
- K860076 — GAMBRO ULTRASONIC BLOOD LEVEL DETECTOR ULD 10-200
- K860372 — FAST FLOW XX (AQUEOUS SOLUTION FILTER)
- K860487 — URENAMEL, POSTERIOR RESTORATIVE MATERIAL
- K860619 — ES 180-DCM MUSCLE STIMULATOR
- K861041 — ENHANCE
- K861247 — CURAMED 402 DIATHERMY UNIT
- K861248 — CURAPULS 419 DIATHERMY UNIT
- K861261 — OHMEDA POSI-PULSE SUCTION UNIT
- K861310 — STOCKERT-SHILEY AORTIC ROOT CANNULAE
- K861322 — RMI POROUS VENT PLUG
- K861441 — NEUTRALON SURGICAL GLOVES
- K861455 — MODEL DT-102 DATA TELEPHONE TRANSMITTER
- K861530 — SURGICAL PACKS, KITS AND TRAYS
- K861571 — TYPE 6500 HEARING AID ANALYZER
- K861765 — ACS WHOLEY HI-TORQUE GUIDE WIRE
- K861859 — CABOT VIDEOSCOPE
- K861876 — CRANIO BLADES AND WIRE PASS DRILL
- K861877 — BYRON WORD BARTHOLIAN GLAND CATHETER
- K861915 — SURGICAL HEAD SUPPORT
- K861923 — STERILE DISPOSABLE SUCTION TUBE CATHETER
- K861943 — PCI CUSTOM DESIGN SERIES
- K861971 — XOMED AUDIANT BONE CONDUCTOR W/IMPROVED AA COIL
- K860677 — EASY EYES TM LENS CARRYING CASE
- K860829 — CNS 4/8 AND CT 48.1 SOFTWARE
- K860906 — STRATUS IMMUNOASSAY CONTROLS, LEVELS I, II, III
- K861048 — PREKALLIKREIN DEFICIENT PLASMA, CAT. NO. B 6765
- K861049 — HIGH MOLECULAR WEIGHT KININOGEN(HMWK) DEF PLASMA
- K861097 — TRYPSIN RIA KIT
- K861269 — RAICHEM AMYLASE REAGENT
- K861367 — KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (THEO)
- K861393 — EMIT COLUMN DIGOXIN ASSAY
- K861394 — EMIT DIGOXIN MOBILE PHASE SOLUTION
- K861397 — OHMEDA 5300 ANESTHETIC AGENT MONITOR
- K861424 — ADAPTABLE CLASS III MASK
- K861638 — KINETIC ALKALINE PHOSPHATASE REAGENT KIT
- K861642 — LENSKEEPER CONTACT LENS CARRYING CASE
- K861651 — TOTAL BILIRUBIN PROCEDURE
- K861652 — IRON PROCEDURE
- K861656 — AST/GOT PROCEDURE
- K861657 — CALCIUM PROCEDURE
- K861658 — ALT/GPT PROCEDURE
- K861662 — LACTATE DEHYDROGENASE (LD) PROCEDURE
- K861667 — ALKALINE PHOSPHATASE PROCEDURE
- K861672 — GAMMA GLUTAMYL TRANSFERASE PROCEDURE
- K861675 — ACID PHOSPHATASE PROCEDURE
- K861712 — WETTING & SOAKING HARD CONTACT LENS SOLUTION
- K861718 — AMYLASE REAGENT CATALOGUE NOS. 85108 AND 85109
Data sourced from openFDA. This site is unofficial and independent of the FDA.