Atlas FDA

FLK

33 FDA 510(k) clearances · Product code

72 daysmedian time to decision
152 days90th percentile
33clearances measured

FDA profile

Official device name
Thermometer, Clinical Mercury
Device class
Class II (moderate risk)
Regulation
21 CFR 880.2920
Medical specialty
General Hospital
Adverse events (MAUDE)
1998: 7 · 1999: 7 · 2000: 2 · 2001: 2 · 2003: 1 · 2006: 3
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
AMSINO CLINICAL THERMOMETER (K960185)Amsia Intl., Inc.1996-03-28
GERATHERM MERCUIRY FREE CLINICAL THERMOMETER (K960224)Rg Ent., Inc.1996-03-25
KENTEMP (K953465)Kentron Health Care, Inc.1995-12-15
CLINICAL GLASS THERMOMETER (K942483)Makol Medical Instruments Corp.1995-03-28
MEDIAID UNIVERSAL THERMOMETER (K941673)Polymedica Industries, Inc.1994-08-25
AMG MED BRAND CLINICAL GLASS THERMOMETER (K940380)Amg Medical, Inc.1994-05-04
AMG MED BRAND CLINICAL GLASS THERMOMETER (K940394)Technolab Industries (Canada) , Ltd.1994-05-04
GUARDIAN AND ANDINO MODELS (K932991)Coltemp, Inc.1994-01-28
LORREX HEALTH PRODUCTS - CLINICAL MERCURY THERMOME (K923225)Lorrex Health Products1993-06-08
SIMPEX INC. ORAL AND RECTAL THERMOMETERS (K913793)Simpex, Inc.1991-12-30
MERCURY AND GLASS FEVER THERMOMETER (K911269)Steridyne Corp.1991-05-15
CLINICAL THERMOMETER; RECTAL/ORAL, INNER ARMPIT (K902625)Liaoning-Usa Corp.1990-10-26
MASCOT THERMOTER (K903500)Mascot, Inc.1990-10-09
THERMOMETER, MERCURY/CLINICAL (K901790)Perlink USA, Inc.1990-07-11
MERCURY THERMOMETERS (ORAL AND RECTAL) (K900646)Abel Industries, Inc.1990-07-11
CLINICAL MERCURY THERMOMETER (K897054)Cypress Medical Products, Ltd.1990-03-22
GLASS MERCURY FILLED THERMOMETERS (K893602)Smith & Nephew United, Inc.1989-08-08
THERMOMETER, MERCURY/CLINICAL (K883573)Umax Corp.1988-11-07
THERMOMETER SHEATHES, STERILE (GLASS) (K870285)The Medical Group, Inc.1987-02-12
INOX THERMOMETER JAR (K852301)Broadwest Corp.1985-07-01
DISPOSABLE THERMOMETERS (K822502)Hudson Oxygen Therapy Sales Co.1982-09-24
THERMOMETER SHEATHS (K813423)Abco Dealers, Inc.1981-12-18
THERMOMETERS (K813424)Abco Dealers, Inc.1981-12-18
THERMOMETER (MADE IN CHINA) (K811631)Robert I. Chien & Assoc., Inc.1981-07-20
FERTILITY AWARENESS METHOD KIT (K801791)Telesis Corp.1980-10-31
DISPOSABLE TEMPERATURE PROBE (K792426)Hospitak, Inc.1980-01-16
TEMPO2-II DISPOSABLE THERMOMETERS (K790891)Airlife, Inc.1979-06-27
OVU-GUIDE (K781817)Reproduction Research Laboratories1978-12-04
THERMOMETER, EXACTA TEMP (K781106)S.M.B. Celsius Co., Inc.1978-08-10
THERMOMETER KIT (K780591)Abco Dealers, Inc.1978-04-19
THERMOMETER SHEATHS (K772365)Medline Industries, Inc.1978-01-26
DISPOS-A-CARE THERMOMETER SHEATH (K770125)Chesebrough-Pond'S U.S.A. Co.1977-03-14
THERMOMETER STAND AND DUST COVER (K760552)Landmark Plastics1976-11-12

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