FDA 510(k) clearances — page 1669
clearances on record, most recent first.
Clearances — page 1669
166,801–166,900 of 175,890- K801525 — ZEST ENDODONTIC STABILIZER
- K801526 — SURVEYOR I, RESPIRATORY COMPUTER SYSTEM
- K801531 — ARM SLING
- K801548 — PERF-LOCK IMPRESSION TRAY
- K801551 — ARGYLE SAF-T-MARK SUCTION CATHETER
- K801557 — ROLLS ROLLITE WHEELCHAIR
- K801565 — CYBREX PHENYTOIN
- K801566 — CYBREX PHENOBARBITAL
- K801567 — CYBREX THEOPHYLLINE
- K801587 — ASH BLUEPRINT ALGINATE IMPRESSION MATER.
- K801591 — FIBER OPTIC ILLUMINATOR
- K801592 — FIBER OPTIC HOSE
- K801620 — ASPIRATOR
- K801435 — ORGANON ARTERIAL BLOOD SAMPLER
- K800624 — LOW-ACETATE HEMODIALYSIS BATH CONCENTR.
- K800627 — AMBULATORY INFUSION PUMP, CODE 2M9807
- K800787 — ANTIBODY TO VARICELLA-ZOSTER VIRUS
- K800957 — DOUCHE UNIT-1500 ML DISP. CONTAINER
- K801138 — MODEL P-380 PHYSIOLOGICAL PRESSURE TRAN.
- K801211 — COBE HEMOFLO BLOOD TUBING SETS
- K801239 — STERILE, DISP DOME, INDIVID. PKG.
- K801265 — WHITE BLOOD CELL COUNT CONTROL LEVELS
- K801267 — RED BLOOD CELL COUNT & HEMATOCRIT CNTL
- K801268 — HEMOGLOBIN CONTROL LEVELS
- K801299 — COBAS CK-NAC REAGENT
- K801318 — HELENA ULTRA SENSITIVE CPK REAGENT/DILUE
- K801350 — ACUVAC(TM) SUCTION RESERVOIR 400CC AND
- K801360 — CARDIOTOMY RESERVOIR WITH FILTER
- K801373 — BECKMAN MODEL 42 SPECTROPHOTOMETER
- K801375 — SHILEY CARDIOTOMY RESERVOIR W/FILTER
- K801378 — HIPP BUFFER(NON-BARBITAL), P/N
- K801386 — PRE-DENT SYSTEM OR PRE-DENT II
- K801391 — DISC 120 TRANSPORTER
- K801409 — GAMMADAB B-HCG RADIOIMMUNOASSAY KIT
- K801425 — RH CONTROL
- K801437 — DISPENSING SEROLOGICAL PIPET
- K801442 — P-S SURGICAL DRAIN
- K801443 — P-S SUCTION RESERVOIR
- K801444 — SKIN STAPLE REMOVER #523770
- K801445 — SKIN STAPLER HANDLE 523700/CARTRIDGES
- K801452 — OROTRACHEAL INTUBATION ENDOSCOPE
- K801457 — ACCU-CORE DISPOSABLE BIOPSY NEEDLE
- K801470 — MICRO CLIP STERILIZING CASE #65199
- K801489 — EZ ON SAFETY PONCHO
- K801490 — DIGOXIN EIA KIT
- K801509 — HI-M-TEST FOR METHADONE TEST #2
- K801514 — TIMETER PRODUCED PURRITAN BENNETT O2 ADP
- K801516 — PRE-DENT SYSTEM MODIFIED
- K801523 — MODEL 379 WXYGEN CONCENTRATOR
- K801534 — LARES AIR PRESSURE GAUGE
- K801544 — PORTA-FIB LPD
- K801549 — MODEL R11 SINGLE CHANNEL CHART RECORDER
- K800768 — VASCULAB BI-DIRECTIONAL DOPPLER, #D10
- K800803 — NITRATE SWAB-RAPID TEST
- K800816 — HIPPUR-ASE TUBES
- K801011 — AVL #980 ELECTROLYTE ANALYZER
- K801020 — GAMMA PROLACTIN RADIOIMMUNOASSAY KIT-
- K801038 — ADAPTAID ELEMA LEAD ADAPTER KIT 365-17
- K801106 — MULTICOR (GAMMA) MODEL 336 & MODEL 337
- K801168 — COLLIMAX X-RAY COLLIMATOR # R-182
- K801177 — ASO QUANTUM, ANTISTREPTOLYSIN O TEST
- K801236 — REIGNING EPOXY RESIN CEMENT
- K801269 — SERALYZER BLOOD UREA NITROGEN(BUN)
- K801270 — TEST FOR KETONE IN URINE(ACETOACETIC AC
- K801286 — PORTA-NEB(R) 310
- K801291 — EC-4 PLETHYSMOGRAPH
- K801295 — COBAS REAGENT FOR A-AMYLASE
- K801298 — COBAS REAGENT FOR TRIGLYCERIDES & COBAS
- K801300 — DUPONT 'ACA' CONJUGATED BILIRUBIN(CBIL)
- K801335 — UNASSAYED CHEMISTRY SERUM CONTROL(BOVINE
- K801342 — DISPOSABLE ARTICULATOR
- K801345 — KAMPNER HINGED TOE PROSTHESIS
- K801352 — HEMORRHOIDAL LIGATION INSTR. SYSTEM
- K801354 — BIONICS ARTERIAL/VENOUS FISTULA NEEDLE
- K801355 — BIONICS BI-FLO STRETCH(DOUBLE LUMEN FOR
- K801356 — BIONICS BI-FLO SAFE(DOUBLE LUMEN CATHET
- K801380 — CROWN DELTA SILICONE IMPRESSION MATERIAL
- K801384 — MYELOSTAT DORSAL CORD STIMULATOR, ETC.
- K801413 — AMERLEX DIGOXIN RIA KIT
- K801422 — SANDARE LYOPHILIZED GLYCOHEMOGLOBIN CLS.
- K801430 — CONTROL SYRINGE
- K801432 — HEMOPEXIN NEPHELOMETRIC ASSAY
- K801433 — HAPTOGLOBIN NEPHELOMETRIC ASSAY
- K801434 — J.T. BAKER TRANSFERRIN NEPHELOMETRIC ASS
- K801475 — APPLICATION OF EMIT AED ASSAYS
- K801476 — APPLICATION OF EMIT THEOPHYLLINE ASSAY
- K801485 — SERIES 602 CKG RECORDER (MODIFIED)
- K801515 — ABBY II PATIENT MONITOR OR VITAL SIGNS M
- K800789 — RUBELLA BIO-BEAD TITRATION KIT
- K800795 — PERMANENT & TEMP. PACEMAKER ELECTRODE
- K800830 — SIEMENS-ELECTROGERATE GMBH MICRO-INHALER
- K800834 — SER-TEX
- K800837 — PROGRAMMABLE BIPOLAR CARDIAC GENERATOR
- K801040 — GE LEAD ADAPTER, MODEL 345-01
- K801045 — GF120H DIALYZER
- K801076 — WAKO PHOSPHOLIPIDS TEST
- K801121 — MICROTHIN-P1 (MOD. 0622)
- K801122 — MICROTHIN-D1 (MOD. 0620)
- K801129 — QUICKTAN BOOTH
- K801149 — BEL O SOL UVA SUNLAMP DEVICE
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