Atlas FDA

LDE

28 FDA 510(k) clearances · Product code

68 daysmedian time to decision
189 days90th percentile
28clearances measured

FDA profile

Official device name
Stethoscope, Manual
Device class
Class I (low risk)
Regulation
21 CFR 870.1875
Medical specialty
Cardiovascular
Adverse events (MAUDE)
1993: 1 · 1999: 1 · 2003: 2 · 2005: 2 · 2006: 2
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
CYPRESS MEDICAL PRODUCTS STETHOSCOPE (K945082)Cypress Medical Products, Ltd.1994-12-08
VARIOUS STETHOSCOPES (K944337)Rud Riester GmbH & CO KG1994-11-30
MANUAL STETOSCOPE (K940578)Bhs Intl., Inc.1994-04-26
PROSCOPES AND ADSCOPES (K935944)American Diagnostic Corp.1994-03-03
STETHOSCOPE COVER (K923327)Anup Chakraborty Co.1992-11-03
TIMEOSCOPE AND FLEXISCOPE (K924095)Stethoscopes of America, Inc.1992-10-20
STETHOSCOPE (K914100)Atlas Medical Products, Inc.1991-11-07
MAXI-SCOPE OR ULTRA-SCOPE (K912128)Seiichi Mfg., Inc.1991-06-28
VARIOUS TYPES OF STETHOSCOPES (K905487)Liaoning-Usa Corp.1991-04-09
STETHOSCOPE (K904547)Kimball Industries Co., Ltd.1991-03-21
V*S*R(TM) SCOPE (K895545)Vsr Enterprises Corp.1989-11-15
KAMED STETHOSCOPE (K890126)D.R.G.1989-04-21
STETH-SHIELD ACCESSORY TO A STETHOSCOPE (K882324)Steth-Shield, Inc.1988-07-18
VARIOUS TYPES OF: KEELER MAGNATONE 2 STETHOSCOPES: (K871369)Keeler Instruments, Inc.1987-09-24
DIFFERENTIAL STETHOSCOPE W/DUAL HEADS; STEREOSCOPE (K860473)Schering Corp.1986-08-14
SALTZMAN STETHOSCOPE HEAD (K854771)K & S Medicorp1986-05-09
LITTMAN TYPE SH-6010, NURSE TYPE (K842203)Cher Mel Corp.1985-06-06
SPRAGUE RAPPAPORT/SH-6008 DISPOS. STETH (K843324)Cher Mel Corp.1985-06-06
THE BLOOM STETHOSCOPE (K830796)Stethophonics, Inc.1983-07-19
LITTMAN TUNABLE STETHOSCOPE 2136 (K821909)3M Company1982-07-14
CARDIOSONIC ACOUSTIC AMPLIFIER (K813510)Srs Co.1982-01-12
AMPLITONE-3 (K812676)Progressive Technology, Inc.1981-10-13
PALPATION ENHANCER (K801811)Medical Horizons Co.1980-09-09
CONPHAR SPRAGUE RAPPAPORT STETHOSCOPE (K801184)Conphar, Inc.1980-06-04
CONPHAR BOWLS STETHOSCOPE (K801185)Conphar, Inc.1980-06-04
ABCO PEDIATRIC STETHOSCOPE (K801215)Abco Dealers, Inc.1980-06-04
CONPHAR DUAL HEAD STETHOSCOPE (K801183)Conphar, Inc.1980-06-04
BLACK BAG, ELECTRONIC (K780023)Marshall Electronics, Inc.1978-02-21

Track LDE automatically

Every clearance here is in the API, with alerts when new ones post.