Atlas FDA

1989

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

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RecordFirmDate
PATIENT EXAMINATION GLOVES (K892963)Mao Gang Industrial Co.1989-08-31
QUIKREAD WHOLE BLOOD HDL-CHOLESTEROL TEST KIT (K894057)Photec Diagnostics, Inc.1989-08-31
UREA NITROGEN TEST (BUN) ITEM #65408 (K894378)Em Diagnostic Systems, Inc.1989-08-31
EMDS CREATINE KINASE ITEM NIMBER 65411 (K893691)Diagnostic Systems1989-08-31
PATIENT EXAMINATION GLOVES (LATEX) (K891730)Athena Mfg., Inc.1989-08-31
LI WAH LATEX EXAMINATION GLOVES (K891323)Li Wah-Hong Kong, Inc.1989-08-31
REP HDL-8 KIT, NO. 3188, REP HDL-16 KIT, NO. 3187 (K894366)Helena Laboratories1989-08-31
MICROMED LATEX EXAMINATION GLOVES (K891793)Siamland, Inc.1989-08-31
DPC-ROBOSTAT(TM) (K894710)Diagnostic Products Corp.1989-08-31
ROCHO ISOMUNE - LD (K894081)Roche Diagnostic Systems, Inc.1989-08-31
POSITIVE AND NEGATIVE HCG URINE CONTROLS (K894181)Armkel, LLC1989-08-31
MAGNESIUM TEST ITEM NUMBER: 65419 (K894508)Em Diagnostic Systems, Inc.1989-08-31
MODIFIED MODEL 570 CLINICAL CHEMISTRY ANALYZER (K893838)Ciba Corning Diagnostics Corp.1989-08-31
PATIENT EXAMINATION GLOVES (K893085)Jiangsu Medicines & Health Products Import & Expor1989-08-30
EB VCA STAT M TEST KIT (K894235)Whittaker Bioproducts, Inc.1989-08-30
THE HANDSCAN SYSTEM (K893455)Digital Body Systems, Inc.1989-08-30
BIOTROL RUB-E.I.A. TEST G (K894544)Biotrol, USA, Inc.1989-08-30
STAPLE FIXATION SYSTEM (K894929)Concept, Inc.1989-08-30
PATIENT EXAMINATION GLOVE (LATEX) (K891504)Lon Tai Chemical Industrial Co., Ltd.1989-08-30
CYPRESS CANNULATED BONE SCREW (K894830)Cypress Medical Mfg., Inc.1989-08-30
DMI 250 SERIES POWER SURGERY TABLE (K894789)M.D. Intl., Inc.1989-08-29
MODELS 4000,4900,6000,8000,8900 ND YAG 1700ND (K894164)Heraeus Lasersonics, Inc.1989-08-29
LATEX EXAMINATION GLOVES (K894324)M/S Overseas Latex Pvt. , Ltd.1989-08-29
LATEX PATIENT EXAMINATION GLOVES (K894773)Transrich Industries Sdn. Bhd.1989-08-29
PATIENT EXAMINATION GLOVES (K894125)Yaw Chang Enterprises Co., Ltd.1989-08-29
TIGER PATIENT EXAM GLOVES (K892978)Daesung America Co., Inc.1989-08-29
MED-TECH RADIOLUCENT HEAD FIXATION SYSTEM (K893911)Medical Equipment Development Co., Inc.1989-08-29
PHYNE-TOUCH-STERILE (K894212)Medical Resources, Ltd.1989-08-29
HARCROS EXAMINATION GLOVES (K893823)H&C Rubber Products Sdn. Bhd.1989-08-29
PUMP-JECT SYRINGE WITH LUER-LOCK (K894041)Ziehm International, Inc.1989-08-28
DIGITAL TRANSTELEPHONIC ECG MONITORING SYSTEM (K892370)Bio-Focus, Inc.1989-08-28
STATSPIN MINI-PLASMA (K893613)Statspin Technologies1989-08-28
FPR CARBAMAZEPINE CALIBRATOR KIT (K894520)Colony Laboratories, Inc.1989-08-28
FPR PHENOBARBITAL CALIBRATOR KIT (K894526)Colony Laboratories, Inc.1989-08-28
CK-MB/LD-1 CONTROL SYSTEM (K894207)Boehringer Mannheim Corp.1989-08-28
PATIENT EXAMINATION GLOVES (LATEX) (K892047)Gainlite Co., Ltd.1989-08-28
COUGH PILLOW (K893809)Custom Hospitals Products1989-08-28
POWER EXAMINATION TABLE MODEL # 411 (K894134)Midmark Corp.1989-08-28
MULTI-DRUG(TM) INFUSION SYSTEM (K892210)I-Flow Corp.1989-08-28
ABUSCREEN POSITIVE REFERENCE CONTROLS (K894464)Roche Diagnostic Systems, Inc.1989-08-28
HOBBS MEDICAL MICROBIOLOGY BRUSH (K893729)Hobbs Medical, Inc.1989-08-28
PATIENT DATA MANAGEMENT SYSTEM (PROJECT 735) (K894230)Siemens Medical Laboratories, Inc.1989-08-28
IVAC(R) SPACE.SAVER(TM) VOLUMETRIC PUMP MODEL 599 (K894037)Y1989-08-28
EMDS TRIGLYCERIDE (TRIG), ITEM NUMBER 65421 (K893917)Em Diagnostic Systems, Inc.1989-08-28
POWER EXAMINATION TABLE MODEL # 405 (K894144)Midmark Corp.1989-08-28
THERA-MIST HUMIDIFIER (K894000)Pegasus Research Corp.1989-08-28
RCI VIRAL/BACTERIAL FILTER (K892230)Respiratory Care, Inc.1989-08-28
EMDS CHOLESTEROL (CHO), ITEM NUMBER 65410 (K893916)Em Diagnostic Systems, Inc.1989-08-28
FPR PHENOBARBITAL KIT (K894525)Colony Laboratories, Inc.1989-08-28
THERA-MIST(TM) NEBULIZER, MODEL 30000 (K893942)Pegasus Research Corp.1989-08-28
DANEK WRIST FIXATOR (K891066)Danek Medical, Inc.1989-08-28
VERICORD S3 (K894123)Philips Medical Systems, Inc.1989-08-28
URIC ACID TEST ITEM NUMBER 65422 (K894287)Em Diagnostic Systems, Inc.1989-08-28
WATER PIK(R) (K894015)Teledyne Water Pik1989-08-28
PREMIER-TOTAL HIP (K894051)Intermedics Orthopedics1989-08-28
FPR CARBAMAZEPINE KIT (K894519)Colony Laboratories, Inc.1989-08-28
TOMAX ULTRASCAN (K892653)Incubation Industries, Inc.1989-08-28
LATEX EXAMINATION GLOVES, NON-STERILE (K892045)C.N. Technocrats1989-08-25
ADX COCAINE METABOLITE (K890788)Abbott Laboratories1989-08-25
EVERGOOD BRAND (PATIENT EXAM GLOVES-LATEX) (K891667)San HU Chemical Industry Co., Ltd.1989-08-25
ADX TM PHENCYCLIDINE (K890688)Abbott Laboratories1989-08-25
PATIENT EXAMINATION GLOVES (LATEX) (K892034)Sistem Med-Pro (M) Sdn Bhd1989-08-25
EDENTRACE 670 SYSTEM MULTICHANNEL RECORDER W/OXIM. (K893561)Edentec Corp.1989-08-25
MINIX 8341M AND MINIX ST 8331M PULSE GENERATORS (K894055)Medtronic Vascular1989-08-25
PULSE TIME PRODUCTS LIMITED, PM-3 (K892795)Pulse Time Products, Ltd.1989-08-25
HOME BLOOD PRESSURE KIT, ANEROID (K884420)Yamasu Co. , Ltd.1989-08-25
PATIENT EXAMINATION GLOVES (LATEX) (K892413)Beijing Jian Xing Latex Products Co., Ltd.1989-08-25
PULSE TIME PRODUCTS LIMITED, PM-2 (K892794)Pulse Time Products, Ltd.1989-08-25
DISPOSABLE LATEX EXAMINATION GLOVES (K892179)Rex Latex Products Co., Ltd.1989-08-25
AD X(TM) ETHANOL (K890743)Abbott Laboratories1989-08-25
ADX CANNABINOIDS (K890693)Abbott Laboratories1989-08-25
ADX TM BARBITURATES (K890690)Abbott Laboratories1989-08-25
MODEL 5650 OPTIMATE PERSONAL PROGRAMMER (K884522)Teletronics, Inc.1989-08-25
CORRECT TOUCH EXAMINATION GLOVES (LATEX) (K892175)Ampri Rubberware Industries Sdn Bhd1989-08-25
ADX AMPHETAMINE/METHAMPHEAMINE (K890692)Abbott Laboratories1989-08-25
MODEL 3110 HEART WIRE & 3110P PEDIATRIC HEART WIRE (K890988)Pace Medical1989-08-25
ADX TM OPIATES (K890689)Abbott Laboratories1989-08-25
DAMOR CREAM SATURATED DRESSING (K891097)Damor America, Inc.1989-08-25
ADX TM BENZODIAZEPINES (K890691)Abbott Laboratories1989-08-25
MODIFIED MATERIAL USED IN INFUSION T (K893909)Quinton, Inc.1989-08-25
CO2 SURGICAL LASER SYSTEM (K894074)Niic U.S.A., Inc.1989-08-24
PATIENT EXAMINATION GLOVES (VINYL) (K892793)Zest Mark Industrial Co., Ltd.1989-08-24
MOTILITY ORBITAL IMPLANT (K891137)Integrated Orbital Implants, Inc.1989-08-24
HOUTS HYSTERECTOMY DRAIN (K894220)Helix Medical, Inc.1989-08-24
LATEX EXAMINATION GLOVES (K894197)Medicare Industries, Inc.1989-08-24
LATEX EXAMINATION GLOVES (K893492)Modern Rubber Industrial Co., Ltd.1989-08-24
LATEX EXAMINATION GLOVES (K893346)Avt Rubber Products , Ltd.1989-08-24
MEDPRIDE LATEX EXAMINATION GLOVES (K894569)Transcorp1989-08-24
LATEX PATIENT EXAMINATION GLOVES (K894774)American Rubber Industries1989-08-24
ANTI-SM MICROASSAY (K894894)Diamedix Corp.1989-08-24
PATIENT EXAMINATION GLOVES (LATEX) (K892791)Union Industrial Co., Ltd.1989-08-24
ELECTRONIC BLOOD PRESSURE MONITORS (K894062)Hanson Scale Co.1989-08-24
KOBAYASHI HOOK AND TWIST KOBAYASHI HOOK (K893655)American Orthodontics1989-08-23
DIRECTABLE COAXIAL CATHETER SET (K894716)Cook Ob/Gyn1989-08-23
PEGASYS NUCLEAR MEDICINE IMAGING COMPUTER (K892358)Adac Laboratories1989-08-23
MICROGYN II ELEC STIM DEVICE TREAT OF URIN INCONTI (K891773)Hollister, Inc.1989-08-23
DISPOSABLE LATEX EXAMINATION GLOVES (K892171)Soh King Neng & Sons Sdn Bhd1989-08-23
LATEX EXAMINATION GLOVES (WINTEX) (K892174)Windwell Agencies Sdn. Bhd.1989-08-23
KALTOCARB WOUND DRESSING (K894347)Calgon Vestal Div.1989-08-23
PATIENT EXAMINATION GLOVE (LATEX) (K892043)Mwe Asia America Industries Sdn1989-08-23
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Every clearance here is in the API, with alerts when new ones post.