Atlas FDA

1989

5,030 FDA 510(k) clearances · Clearance year

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RecordFirmDate
DC-4 SHUNT INFUSION T (K891754)Akcess Medical Products, Inc.1989-04-07
PATIENT EXAMINATION GLOVES (LATEX) (K891743)Dispotex Industries Sdn. Bhd.1989-04-07
SPECBOARD (K891090)Macbrud Corp. Medical Div.1989-04-07
FC-101 FEMORAL CATHETER GUIDE WIRE (K891764)Akcess Medical Products, Inc.1989-04-07
PERFECTA II/NON-COATED TOTAL HIP SYSTEM (K884027)Orthomet, Inc.1989-04-07
BALLOON (NEPHROSTOMY TRACT) DILATION CATHETER SET (K891406)Cook Urological, Inc.1989-04-07
ABSORBENT GAUZE ROLL (K890672)Smith & Nephew United, Inc.1989-04-07
ORTHODONTIC ARCH AND SURGICAL HOOKS (K891592)American Orthodontics1989-04-07
GOLD CLASS, GRANDTEX, LATEX EXAMINATION GLOVES (K891648)Harry Panzer Intl. Corp.1989-04-07
DA-46 FLUID BARRIER (K891752)Akcess Medical Products, Inc.1989-04-07
FC-100 FEMORAL CATHETER (K891763)Akcess Medical Products, Inc.1989-04-07
ULTRASOUND PROCEDURE TRAY AMNICENTESIS TRAY (K890463)Critical Specialties, Inc.1989-04-07
OMNIFIT CONSTRAINED ACETABULAR BEARING INSERT (K890197)Osteonics Corp.1989-04-07
PATIENT EXAMINATION GLOVES (LATEX) (K891508)Safeway Products, Inc.1989-04-06
MICRO CAUTERY NEEDLES (K891400)Zinnanti Surgical Instruments, Inc.1989-04-06
RIBBON TYPE SCISSORS: TENOTOMY,IRIS,EYE,STRABISMUS (K891200)Zinnanti Surgical Instruments, Inc.1989-04-06
THE C-S DISTRACTION ROD ASSEMBLY (K890187)Orthopedic Systems, Inc.1989-04-06
TSRH ANTERIOR SPINAL SCREWS, STAPLES AND END PLATE (K883784)Warsaw Orthopedic, Inc.1989-04-06
LATEX EXAMINATION GLOVES NON-STERILE (K890356)Quest Intl., Inc.1989-04-06
TSRH SACRAL SPINAL SCREW (K883783)Warsaw Orthopedic, Inc.1989-04-06
PATIENT EXAMINATION GLOVES (LATEX) (K891507)Purna Bina Sdn Bhd1989-04-06
PATIENT EXAMINATION GLOVES (LATEX) (K891260)The Glove Outlet, Inc.1989-04-06
KIRSCHNER RETRACTOR (K891031)Zinnanti Surgical Instruments, Inc.1989-04-06
VINYL PATIENT EXAMINATION GLOVE (K890987)Jm Gloves Co., Ltd.1989-04-06
MEDI-TRACE THERMAL VIDEO FILM PAPER (K891192)Graphic Controls Corp.1989-04-06
SCISSORS: THOREK, JORGENSEN, FINOCHIETTO (K891203)Zinnanti Surgical Instruments, Inc.1989-04-06
KATZEN THROMBOLYSIS GUIDEWIRE (K883880)Medi-Tech, Inc.1989-04-06
PHACOEMULSIFIER MODEL 100 (K890080)Sonic Needle Corp.1989-04-06
PATIENT EXAMINATION GLOVE (K891017)Paramount Products, Inc.1989-04-06
DEVILBISS MODEL 1400D (OXYGEN CONSERVING DEVICE) (K890141)Devilbiss Health Care, Inc.1989-04-06
COOL 'N HEAT MACHINE (K891151)Kinetic Concepts, Inc.1989-04-06
C-S IMPACTOR (K890185)Orthopedic Systems, Inc.1989-04-06
CARRETTE 3 WHEELED MOTORIZED CART (K891609)Everest & Jennings, Inc.1989-04-06
HEMOSTATIC FORCEPS BRUNS.,GEMINI,SPENCER-WELL,KANT (K891401)Zinnanti Surgical Instruments, Inc.1989-04-06
SURGILASE YAG 100 SURGICAL ND:YAG LASER/GEN SURG (K891461)Surgilase, Inc.1989-04-06
PATIENT EXAMINATION GLOVE (K890593)Industri Getah Jacon1989-04-05
TELE-TEMP THERMOMETER (K890202)Rocky Mountain Medical Corp.1989-04-05
NON-STERILE PATIENT EXAMINATION GLOVE (K891300)Shun Thai Rubber Gloves Industry Co., Ltd.1989-04-05
SLT CONTACT LASER SYSTEM (ORTHOPEDICS) (K890321)Surgical Laser Technologies, Inc.1989-04-05
SHARPLAN MODEL 750 REMOTE CONTROL UNIT (RCU) (K890286)Sharplan Lasers, Inc.1989-04-05
SLT CONTACT LASER SYSTEM (ENT, HEAD & NECK SURG.) (K890322)Surgical Laser Technologies, Inc.1989-04-05
CONSUMMATE AIR THERAPY BED (K890426)Health Products, Inc.1989-04-05
SUPERMON ARRHYTHMIA MODULE 7270 (K882206)Kontron Instruments, Inc.1989-04-05
MODIFICATION HEMOFILTRATION CATHETER HF-100 (K890717)Vas-Cath, Inc.1989-04-05
FDX SOLID STATE VIDEO CAMERA MODEL 5950 (K891236)Medical Dynamics, Inc.1989-04-05
ENTERAL FEEDING TUBE (K890116)Hdc Corp.1989-04-05
PATIENT EXAMINATION GLOVES (LATEX) (K891416)Sampson Development Corp.1989-04-04
TOTAL BILIRUBIN FOR CONTINUOUS FLOW (K891025)Catachem, Inc.1989-04-04
SAFE MULTIPORT INJECTOR (K884511)L & W Ent.1989-04-04
LINISTAIN SLS (K890984)Shandon, Inc.1989-04-04
NON-STERILE PATIENT EXAMINATION GLOVES (K891330)Galaxy Intl., Inc.1989-04-04
CHROMATOGRAPHY KIT (K884176)Gelman Sciences, Inc.1989-04-04
PLEUR-EVAC(R) A-8000--ADULT/PEDIATRIC CHEST DRAIN (K890431)Deknatel, Inc.1989-04-04
STERILE PATIENT EXAMINATION GLOVES (K891329)Galaxy Intl., Inc.1989-04-04
PATIENT EXAMINATION GLOVES (LATEX) (K891649)Lic-Orthion1989-04-04
BUTTERFLY GLOBE (PATIENT EXAMINATION GLOVE) (K890982)O.L. Trading, Inc.1989-04-04
VINYL PATIENT EXAMINATION GLOVE (K890986)Precious Mountain Ent. Corp.1989-04-04
TROJAN FOR WOMEN (K890863)Armkel, LLC1989-04-04
GIARDEIA(TM) (K890774)Antibodies, Inc.1989-04-04
GLUCOFILM TEST STRIPS & CONTROLS/GLUCOMETER 3 (K890873)Heraeus Kulzer, Inc.1989-04-04
ALT (GPT) IFCC 2-VIAL REAGENT W/PYRIDOXYL PHOSPHAT (K891469)Trace Scientific , Ltd.1989-04-04
XIMAVIEW(TM) (K884323)Varian Assoc., Inc.1989-04-03
NEEDLE GUARD(TM) (K890473)Martech Medical Products, Inc.1989-04-03
MAGNETIC RESONANCE DIAGNOSTIC DEVICE ACCESSORIES (K890815)Siemens Medical Solutions USA, Inc.1989-04-03
VISUAL REINFORCE. AUDIO CASSETTE UNIT: BASIC & ADV (K880259)Colorado Hearing Systems, Inc.1989-04-03
TECHTON PROTECTIVE PAD (K873038)Techton, Inc.1989-04-03
SCIMED ECMOTHERM(TM) HEAT EXCHANGER (K884560)Scimed Life Systems, Inc.1989-04-03
TRAUMAFUSE RAPID INFUSION DEVICE (K890077)The Traumafuse Co.1989-04-03
RADKOR BS-10 AND BS-10T (K891395)Radkor, Inc.1989-04-03
MANDIBLE MANIPULATOR (K884308)Leonard Medical, Inc.1989-03-31
PERCUSSION HAMMER (K891571)Sandal Surgico1989-03-31
THE SPANTRON FRAME FREEZE (K890477)Spantron, Inc.1989-03-31
BEHIND-THE-EAR HEARING AID MODEL 408 W-H (K891251)Siemens Hearing Instruments, Inc.1989-03-31
PATIENT EXAMINATION GLOVES (LATEX) (K891307)Five Star Rubber Products1989-03-31
NATURAL IMAGE ULTRASOUND TRANSMISSION COUPLANT (K883917)Sonomed Technology, Inc.1989-03-31
DISPOSABLE LATEX EXAMINATION GLOVES (K891322)Duflex Products Sdn. Bhd.1989-03-31
PREFORMED TEMPLATE FOR TOOTH POSITIONER (K891328)American Orthodontics1989-03-31
INTRAVASCULAR ADMINISTRATION SET (K890340)Multi-Med, Inc.1989-03-31
STRETCHER TABLE (K884292)Fischer Imaging Corp.1989-03-31
ABUSCREEN FP BENZODIAZEPHINE REAGENT (K891697)Roche Diagnostic Systems, Inc.1989-03-31
Q-PLEX 1 (K881235)Quinton, Inc.1989-03-31
ORION PLUS W/NONOXYNOL-9 OTHERS (MULTIPLE) CONDOMS (K884469)Mayer Laboratories1989-03-31
ORTHODONTIC PLASTIC BRACKET (K891372)American Orthodontics1989-03-31
ACCULEVEL ONE-STEP THEOPHYLLINE TEST (K885253)Syva Co.1989-03-31
SUPER MAXX OTHERS (MULTIPLE) CONDOMS (K884468)Mayer Laboratories1989-03-31
REUSABLE MLYOCARDIAL BIOPSY FORCEPS (BIOPTOMES (K890453)Dlp, Inc.1989-03-31
PATIENT EXAMINATION GLOVE, LATEX (K890971)Yaung Jenn Co., Ltd.1989-03-31
PHYSIOGARD SM 785 (K885177)Adam1989-03-31
PATIENT EXAMINATION GLOVES (LATEX) (K891546)Ap Intl., Inc.1989-03-31
ROCHE CHLORIDE ELECTRODE (K890528)Roche Diagnostic Systems, Inc.1989-03-31
ACS 0.015 & 0.018 PRESSURE GUIDE WIRE W/MICRO. (K882507)Advanced Cardiovascular Systems, Inc.1989-03-31
GX-2000 STATIONARY X-RAY GENERATOR (K890083)Gendex Corp.1989-03-31
MITYVAC M STYLE VACUUM EXTRACTOR, DISPOSABLE (K890307)Neward Enterprises, Inc.1989-03-31
REVISED MAGNESIUM TEST ITEM NUMBER: SR1019 (K890798)Em Diagnostic Systems, Inc.1989-03-31
CLEARFIL CR INLAY (K890123)Kuraray Co.1989-03-31
7610 COLORVIEW SLAVE SCOPE (K890481)Marquette Electronics, Inc.1989-03-31
PATIENT EXAMINATION GLOVES (LATEX) (K891501)Tan Chong Rubber Gloves Sdn Bhd1989-03-31
PATIENT EXAMINATION GLOVES (LATEX) (K891368)Zest Mark Industrial Co., Ltd.1989-03-31
KIMONO PLUS OTHERS (MULTIPLE) CONDOMS (K884470)Mayer Laboratories1989-03-31
SHEPARD INTRAUTERINE INSEMINATION CATHETER (K890301)Cook Ob/Gyn1989-03-31
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