Atlas FDA

MDM

44 FDA 510(k) clearances · Product code

129 daysmedian time to decision
275 days90th percentile
44clearances measured

FDA profile

Official device name
Instrument, Manual, Surgical, General Use
Device class
Class I (low risk)
Regulation
21 CFR 878.4800
Medical specialty
General, Plastic Surgery
Adverse events (MAUDE)
2021: 227 · 2022: 182 · 2023: 209 · 2024: 507 · 2025: 324 · 2026: 164
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
FRONTLINE MEDICAL SAFETYNET GUIDEWIRE INTRODUCER (K073664)Injectimed, Inc.2008-08-08
FUTUMEDS NO PATIENT CONTACT SAFETY LANCET WITH PALS SYSTEM (K050575)Futumeds Sdn Bhd2005-08-15
EUTROCHAR (K050957)Special Devices, Inc.2005-05-18
ANDREWS INTRODUCER, MODEL ASI01 (K023173)Andrews Surgical Innovations, Ltd.2002-12-18
MICROVASIVE PULMONARY GUIDEWIRE (K022059)Boston Scientific Corp2002-11-13
LIGHT SABER INTRODUCER NEEDLE (K013040)Minrad, Inc.2001-12-07
CHESS HAND SURGERY SYSTEM (K010184)Canica Design, Inc.2001-06-22
SAPHLIFT (K990062)Genzyme Surgical Product (Genzyme Biosurgery)1999-03-30
ENDOPOUCH PRO SPECIMEN RETRIEVAL BAG (K981579)ETHICON, Inc.1998-07-09
TUNNELER (K943968)Denver Biomedicals, Inc.1995-03-01
DERMAVBLADE(TM) (K945430)Hasting'S Biomedical Corp.1994-11-28
EAST WEST INSTRUMENTS (K941193)East West Instruments, Inc.1994-11-09
APEX DISPOSABLE INSTRUMENTS (K941907)Apex Ent., Inc.1994-08-26
DEEP SUTURE (K942818)Automated Medical Products Corp.1994-08-25
CLAMPS AND CLIPS (K942896)Surgin Surgical Instrumentation, Inc.1994-07-19
SURGICAL INSTRUMENT, DISPOSABLE (K940684)Her-Mar, Inc.1994-03-14
ACU-DISPO-CE(TM) (K933265)Acuderm, Inc.1994-03-07
ACU-HEMOSTATIC RING (K933866)Acuderm, Inc.1993-12-01
DERMAPUNCH DISPOSABLE SKIN BIOPSY PUNCH (K925653)Dermatopathology Laboratory1993-11-08
HOSPITAL KIT DK 117 (K922130)Savoy Medical Supply Co., Inc.1993-05-24
SUTUREMATE (K926126)Surgical Safety Products, Inc.1993-05-19
DISPOSABLE FORCEPS, HEMOSTATS, NEEDLE GUIDES, ETC (K930775)Falcon Instruments, Inc.1993-04-23
HOSPITAL KIT GP 103 (K922127)Savoy Medical Supply Co., Inc.1993-03-29
SV 100200 - SINGLE USE ONLY - STERILE HOSPITAL KIT (K923281)Savoy Medical Supply Co., Inc.1993-03-26
HOSPITAL KIT EP 104 (K922128)Savoy Medical Supply Co., Inc.1993-03-23
BREAST STABILIZER (K925874)Bip USA, Inc.1993-03-16
ORC ENDOSCOPIC INSTRUMENT HOLDER (K930399)O.R. Concepts, Inc.1993-02-17
PERSONNA SAFETY SCALPEL (K924503)American Safety Razor Co.1993-02-05
AMERICAN BIOMED, INC. MICROSURGICAL INSTRUMENTS (K924725)American Biomaterials Corp.1993-02-05
CENTURION DISPOSABLE INSTRUMENTS (K923812)Tri-State Hospital Supply Corp.1992-12-17
DISPOSABLE CURETTE (K921022)Dermtec, Inc.1992-12-03
LACERATION REPAIR TRAY (K921988)Cypress Medical Products, Ltd.1992-11-19
FRAY BIO-PUNCH (K921822)Fray Products Corp.1992-10-28
DISPOSABLE FORCEPS (K920296)Falcon Instruments, Inc.1992-09-11
DISPOSABLE SCISSORS (K920297)Falcon Instruments, Inc.1992-09-11
DISPSABLE FORCEPS, HEMOSTATS, PROBES, NEEDLE GUIDE (K922874)Supra Instruments, Inc.1992-09-11
SURGICAL INSTRUMENT STAND (K921210)Murphy Medical Center1992-04-29
QUALTEX LIGHT HANDLE AND LIGHT HANDLE COVER (K911369)Deroyal Industries, Inc.1991-05-13
QUALTEX SUTURE BOOTIES (K911895)Deroyal Industries, Inc.1991-05-08
JAIN SUTURE/VESIBAND ORGANIZER (K905105)Jain Surgical Equipment, Inc.1991-01-31
YANKAUER SUCTION DEVICE (K905478)Medovations, Inc.1990-12-19
SHAVE PREP TRAY (K855132)Dynarex Corp.1986-01-24
SILICONE IMPLANTS (K812691)Sutter Biomedical, Inc.1981-11-16
THE EQUALIZER (K801328)The Anspach Effort, Inc.1980-06-09

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