FDA 510(k) clearances — page 1430
clearances on record, most recent first.
Clearances — page 1430
142,901–143,000 of 175,890- K863337 — CORDIPAK CARDIAC CATHETERIZATION PACK
- K863359 — BOUFFANT-STYLE SURGICAL CAP
- K863388 — QUANTIMETRIX DRUG FREE SERUM CONTROL
- K863403 — PHENYTOIN, AS PERFORMED ON TECHNICON RA SYSTEMS
- K863409 — KUNDIN WOUND GAUGE
- K863419 — EMDS(TM) ALCOHOL TESTPACKS, #67691/95
- K863438 — NOVA II SODIUM/POTASSIUM/LITHIUM ANALYZER
- K863447 — STRYKER ORTHOPOWER 90 & ORTHOPOWER 90 SYSTEM II
- K863486 — POTASSIUM TEST
- K863489 — PARAMAX ELECTROLYTE CALIBRATOR
- K863528 — BICONDYLAR TOE PROSTHESIS
- K863544 — EASY-TEST CARBON DIOXIDE (CO2) ITEM #67649/95
- K863560 — URESIL STD FLAT/ROUND & FLAT/ROUND SPLIT. SILI/DRA
- K863562 — URESIL 150CC BELLOWS RESERVOIR
- K863570 — LE VEEN WOUND SPLINT
- K863588 — AMYLASE PROCEDURE
- K863632 — UPDATED STERILE PROCEDURAL KIT
- K863637 — UPDATED STERILE GOWNS, MASKS AND TOWELS
- K863639 — ARTICULAR MOTION DEVICE (AMD4000)
- K863661 — MEDCOMP DISPOSABLE MANIFOLD SYSTEM
- K863696 — ARTHROSCOPIC SURGICAL POWER DEVICE
- K860680 — PROTEX, TAHITI CONDOM
- K861039 — OMNIVAC (VACUUM ELECTRODE SYSTEM)
- K861929 — PULMONARY FUNCTION TEST LABORATORY, SYSTEM 1070
- K862224 — THE WOOG AND THE WOOG D. POWERED TOOTHBRUSHES
- K862312 — ENZLIPASE, ENZYMATIC LIPASE KIT
- K862377 — QMED SELF ADHERING ELECTRODE
- K862430 — SIEGEN HEADPHONES
- K862498 — ALKALINE PHOSPHATASE TEST
- K862596 — DR-2C (MODIFICATION)
- K862617 — SENSORMEDICS OXYSHUTTLE(TM)
- K863010 — EUROCART SR-4, EUROCART M-IV, ISOCART III
- K863057 — BILIRUBIN TOTAL DIRECT
- K863059 — CALCIOMETER
- K863075 — TRIGLYCERIDES-E
- K863095 — ACE II (TRI-LEVEL)
- K863251 — URIC ACID PROCEDURE
- K863254 — TRIGLYCERIDE (TRINDER) PROCEDURE
- K863256 — CALCIUM PROCEDURE
- K863257 — AST/GOT PROCEDURE
- K863259 — GLUCOSE HK PROCEDURE
- K863301 — DEMAND TOTAL PROTEIN
- K863328 — ACA(R) C-REACTIVE PROTEIN (CRP) ANALYTICAL TEST
- K863329 — ACA(R) C-REACTIVE PROTEIN (CRP) CALIBRATOR
- K863367 — FORMALENS 2000
- K863379 — DERMATEC BURN PADS
- K863422 — DELFIA(TM) CORTISOL KIT
- K863477 — EMDS(TM) LACTIC DEHYDROGENASE TESTPACKS, #67660/95
- K863620 — RAICHEM(TM) CHLORIDE REAGENT
- K863650 — QUANTIMAP III
- K863706 — LOVESAFE CONTRACEPTIVE CONDOMS, TYPE NL-50
- K863707 — LOVESAFE CONTRACEPTIVE CONDOMS, TYPE SC-40
- K862204 — RSL (125I) ALDOSTERONE KIT
- K862336 — PANCOAT CORTISOL COATED TUBE RADIOIMMUNOASSAY KIT
- K862444 — FIBERLASE 100 MEDICAL LASER SYS/ND:YAG MENORRHAGIA
- K862492 — EXEL THREE-WAY STOPCOCK
- K862635 — RABINOWITZ GUM MASSAGER
- K862879 — NEW LIGHT-CURING IMPRESSION MATERIAL
- K862932 — THE BIO-TEK UW-II
- K862952 — CHARTER WETTING SOLUTION FOR HARD CONTACT LENSES
- K862955 — METHODS FOR THE DIMENSION CLINICAL CHEM. SYSTEM
- K862959 — MERIVAARA PATIENT TROLLEY - MODEL #416
- K862968 — FREE T3 RADIOIMMUNOASSAY KIT
- K863009 — GNATUS ARTICULATOR 4.300/4.300GP 8.600 & ORTOFLEX
- K863017 — ISOLAX (GNATUS)/ISOLAX PEDAL/MINILAX
- K863018 — DENTATUS-S / L / LS / (GNATUS)
- K863023 — CABINET II AUXILIARY UNIT
- K863024 — SERINGA TRIPLICE S.L.
- K863062 — CHOLESTEROL-E (TOTAL)
- K863065 — HDL CHOLESTEROL-E
- K863088 — ABBOTT SPECTRUM PHOSPHORUS REAGENT
- K863117 — HIGH PERFORMANCE CANNABINOID CONTROLS
- K863133 — PROPHY CARE PASTE
- K863157 — RESTODENT POSTERIOR
- K863188 — HPL RIA KIT
- K863235 — SURGICAL IOP MONITOR
- K863297 — MODIFICATION'S TO TORAY'S B-2 SERIES
- K863511 — IMMOBILIZING VACUUM MATRESS (IVM)
- K863514 — PROMEDICOR
- K863545 — EASY-TEST LACTIC DEHYDROGENASE (LDH) # 67527/95
- K863592 — DISSCAP 80E, 110E, 140E, 160E
- K863597 — AMERICAN EDWARDS 4.0 MM ARTHROSCOPE
- K863616 — KNIFE MAKER
- K863645 — SCHULMAN DOUBLE UMBILICAL CORD CLAMP NO. 1000
- K863664 — OPHTHALMIC SURGICAL SPECULUM
- K863665 — THE ULTIMATE
- K862455 — MODIFIED CARDIOCAP MONITOR
- K862937 — BUCHBINDER(TM) MULTIFLEX(TM) GUIDEWIRE
- K862987 — MODEL 1000 OPHTHALMIC LASER SYSTEM
- K863008 — -OM WEST 2000 GNATUS CHAIR
- K863217 — DIGILAB MODULAR ONE-APPLANATION TONOMETER
- K863233 — STC 909ZX POWER BASE
- K863415 — RAYLOR BONE IMPACTORS
- K863416 — RAYLOR MINI-PROBE
- K863418 — MODEL 352-01 SILICONE RUBBER ISOLATION SLEEVE
- K863474 — KASEY EYE SHIELD
- K863538 — RESPICENTRAL(TM)
- K861156 — HOSPAL DIALYSATE FOR CAVHD
- K861304 — FAGAN TEST MACHINE FOR INFANT INTELLIGENCE
- K861681 — DENTIMEDIC DENTAL EMERGENCY KIT
Data sourced from openFDA. This site is unofficial and independent of the FDA.