FDA 510(k) clearances — page 1642
clearances on record, most recent first.
Clearances — page 1642
164,101–164,200 of 175,890- K811322 — POTATO DEXTROSE AGAR
- K811323 — NUTRIENT BROTH
- K811324 — PHENYLETHANOL AGAR
- K811325 — SABOURAUD DEXTROSE AGAR
- K811326 — SABOURAUD LIQUID, BROTH MODIFIED
- K811327 — SALMONELLA SHIGELLA AGAR
- K811328 — SCHAEDLER AGAR
- K811343 — HUMERAL FRACTURE CAST BRACE
- K803208 — SIRECUST 358
- K810317 — NITROGLYCERINE IV SET
- K810677 — MODELS 5976/5977 PACEMAKER PULSE GENER
- K810722 — GASTRIN RADIOIMMUNOASSAY TEST
- K810801 — DENTMED V-PACKS
- K810880 — AR-1 PHYSIOLOGICAL PRODESSOR
- K810881 — EMG 3510/EMG 3510D MYOFEEDBACK MONITORS
- K810882 — ASR-3520 SKIN RESPONSE MONITOR; ASR-3520A
- K811017 — HUCKSTEP INTRAMEDULLARY NAIL
- K811030 — APPOSE SKIN STAPLER
- K811059 — PENTAX BRONCHOFIBERSCOPE #FB-15A
- K811068 — BYPASS COIL
- K811106 — INTERMEDICS POLY FLEX ENDOCARDIAL PACING
- K811123 — MEDTRONIC PULSE GENERATOR
- K811157 — BLADE, TONGUE
- K811158 — OMNI
- K811159 — DYNASOUND 801
- K811164 — URETHANE ORTHOPAEDIC CASTING TAPE
- K811171 — VASCULON II I.V. CATHETER
- K811175 — RECOH ROOT CANAL IRRIGATOR
- K811187 — MEDTRONIC A2 CLINICAL IMAGING SYSTEM
- K811191 — DAVIS & GECK NEEDLE/SHARPS COUNTER
- K811194 — HITACHI 705 AUTOMATIC BLOOD CHEMISTRY
- K811202 — ULTRACHEM GLUC-DH, ITEM NO. 65048
- K811221 — INTERMEDICS CYBERLITH BIPOLAR CARDIAC
- K811241 — BODAI SUCTION -SAFE 4
- K811257 — CORNING 965 CARBON DIOXIDE ANALYZER
- K811260 — BARALYME CO2 ABSORBENT
- K811262 — EPSTEIN-BARR VIRUS CAPSID ANTIGEN ANTI
- K811273 — CYCLIC AMP RADIOIMMUNOASSAY KIT [125I]
- K811274 — PROSTATIC ACID PHOSPHATASE RADIOIMM. KIT
- K811289 — NOVA 5
- K811297 — CERVICAL SUPPORT
- K811298 — EXECUTIVE COLLAR
- K811301 — TUBMATE
- K811304 — LIQUID CHROMATOGRAPHY COLUMNS
- K811315 — COAT-A-COUNT T4 RIA KIT
- K803249 — FLUID WARMER
- K810918 — ROLL-A-SET
- K810921 — MALE LUER LOCK PLUGS
- K810973 — SYSTEM 400
- K810995 — PREFILLED PULSATOR SYRINGE
- K811082 — BETA I & BETA II
- K811163 — SUR-FIT DISPOSABLE FANGE CAP
- K811167 — FOCUS STERILE SYRINGES
- K811199 — MARZ-175
- K811201 — EFTEKHAR ACETABULAR STANDOFF
- K811203 — SAF SINGLE-USE AEROSOL FILTER
- K811204 — BRONCHEK-SHILEY CARDIAC JACKET & BSC J
- K811205 — MOLDED POLYSULFONE TRIAL PROSTHESIS
- K811206 — SELF HEATING DISPOSABLE HEAT PAD
- K811208 — MODEL 1100 SPHYGMOMANOMETER
- K811212 — DIGOXIN (RIA) KIT
- K811214 — ASSURE NATURAL FIT TAMPON
- K811219 — KOVA STRIP 6
- K811222 — INORGANIC PHOSPHORUS REAGENTS
- K811223 — VASOVASOSTOMY STABILIZER PLATFORM DEV
- K811232 — DISPOSABLE UNDERPADS
- K811242 — DISPOSABLE STERILIZATION WRAP
- K811249 — TECHNICON SMAC II SYSTEM & ACCESSORIES
- K811251 — CITRATE BUFFER
- K811184 — SPENCO DERMAL PADS
- K810332 — SC/TEMP 300
- K810043 — GOAT ANTI-HERPES SIMPLEX VIRUS TYPE I
- K810396 — APC IMPLANTABLE PACING LEAD, TINED #3262
- K810397 — APC IMPLANTABLE PACING LEAD-FLANGE #3260
- K810398 — APC IMPLANTABLE PACING LEAD, MODEL 3266
- K810399 — APC IMPLANTABEL PACING LEAD, MODEL 3264
- K810734 — MODELS 8420 THRU 8423 PACEMAKER GENER
- K810808 — CORATOMIC MODEL OVALITH-920
- K810894 — FOGARTY FLEXIBLE CALIBRATOR
- K810937 — ANIS IRRIGATING SPATULA
- K811011 — HISTOCHEMICAL DEMONSTRATION OF LEUKOCYTE
- K811015 — POSITIVE CLOSURE ANESTHETIC VALVE
- K811144 — ARIA II INSULIN RIA
- K811150 — URINE PREGNANCY TEST STANDARD/CONTR. PK
- K811151 — COLLARLESS TOTAL HIP FEMORAL COMP. SYS
- K811152 — DADE RPR CARD TEST
- K811169 — PROSTATIC ACID PHOSPHATASE (PAP) RDA KIT
- K811176 — TIGGES SPINAL
- K811177 — QUANTA PHASE VITAMIN B-12/FOLATE RAD
- K811178 — HUMAN IGG-ALBUMIN TEST KIT
- K811179 — OSMOMETER MODEL OM-6010
- K811180 — ULTRAMATIC PROJECT-O-CHART OPHTH. PROJ
- K811182 — MULTIANALYTE CONTROLS, ALL KINDS
- K811188 — NORELCO BLOOD PRESSURE METER
- K810403 — KEELER/KONAN SPECULAR MICROSCOPE
- K810584 — PHADEBAS ISOAMYLASE TEST
- K810641 — K-MED ENCOURAGER INCENTIVE SPIROMETER
- K810768 — MINIMUM ESSENTIAL MEDIUM EAGLE W/HANKS
- K810769 — MINIMUM ESSENTIAL MEDIUM EAGLE W/EARLE
- K810770 — MED. 199(MODIFIED) W/HANKS' SALTS
Data sourced from openFDA. This site is unofficial and independent of the FDA.