FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
81481–81504 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 12, 2000
USS VAS
K002517 · KWP
Synthes (Usa)
Orthopedic · 28d
Cleared Sep 12, 2000
EL-ANA PROFILES-2K1
K002559 · LJM
Theratest Laboratories, Inc.
Immunology · 26d
Cleared Sep 12, 2000
MOSS MIAMI 6.35MM ROD SYSTEM MONOAXIAL SCREWS, POLYAXIAL REDUCTION SCREWS AND...
K002607 · KWP
Depuyacromed
Orthopedic · 21d
Cleared Sep 12, 2000
MEDTRONIC PS MEDICAL POLYURETHANE SHUNT, MODELS 27521, 27116, 20022
K991502 · JXG
Medtronic PS Medical
Neurology · 502d
Cleared Sep 11, 2000
TPN NUTRITION BAG (EVA), EMPTYING TUBE, BAG SYRINGE FILL SET
K001461 · KPE
Biometrix , Ltd.
General Hospital · 124d
Cleared Sep 11, 2000
VIRIDIS LASER
K001784 · GEX
Cosmos Medical Technology
General & Plastic Surgery · 90d
Cleared Sep 11, 2000
ENZYME IMMUNOASSAY ANTI-SSDNA ANTIBODY TEST
K001900 · LRM
Helix Diagnostics, Inc.
Immunology · 81d
Cleared Sep 11, 2000
C02 LASER MULTIPULSE
K002032 · GEX
Asclepion-Meditec AG
General & Plastic Surgery · 70d
Cleared Sep 11, 2000
FMS SOLO
K002040 · HRX
Future Medical Systems, Inc.
Orthopedic · 68d
Cleared Sep 11, 2000
PROLITE VL PULSED LIGHT SYSTEM
K002072 · GEX
Medical Bio Care Sweden AB
General & Plastic Surgery · 66d
Cleared Sep 11, 2000
GOLDEN-RULE SCALING CATHETER
K002416 · DQO
Medical Device Technologies, Inc.
Cardiovascular · 34d
Cleared Sep 11, 2000
LATEX EXAMINATION GLOVES, POWDERED, (CONTAINS 100 MICROGRAMS OR LESS OF TOTAL...
K002448 · LYY
Oon Corp. Resources
General Hospital · 33d
Cleared Sep 11, 2000
FETALTROL
K002511 · JPK
Trillium Diagnostics, LLC
Hematology · 27d
Cleared Sep 11, 2000
DIGITAL BLOOD PRESSURE MONITOR, MODELS HD-503 AND HD-505
K002722 · DXN
Jawon Medical Co., Ltd.
Cardiovascular · 11d
Cleared Sep 11, 2000
INFUSOR PATIENT CONTROL MODULE, 2ML, MODEL 2C1067K
K002739 · MEA
Baxter Healthcare Corp
General Hospital · 10d
Cleared Sep 08, 2000
VITALOGRAPH BASE STATION
K000599 · BZG
Vitalograph, Inc.
Anesthesiology · 199d
Cleared Sep 08, 2000
RESPIRONICS SILHOUETTE NASAL MASK, MODELS 1003224 AND 1003223
K000705 · BZD
Respironics, Inc.
Anesthesiology · 190d
Cleared Sep 08, 2000
HEARTSTREAM XL DEFIBRILLATOR/MONITOR, MODEL M4735A
K001725 · MKJ
Agilent Technologies, Inc.
Cardiovascular · 94d
Cleared Sep 08, 2000
OLYMPUS XGIF-N200H GASTROINTESTINAL VIDEOSCOPE
K001766 · FDS
Olympus Optical Co., Ltd.
Gastroenterology & Urology · 88d
Cleared Sep 08, 2000
PRIMED PLEATED TIE-BACK, PROCEDURE MASK PM4-305, PRIMED PLEATED EAR-LOOP,...
K001951 · FXX
Primeline Medical Products, Inc.
General Hospital · 73d
Cleared Sep 08, 2000
SPIROXCARD DIAGNOSTIC SPIROMETER AND PULSE OXIMETER
K001995 · DQA
Qrs Diagnostic, LLC
Anesthesiology · 70d
Cleared Sep 08, 2000
TAMPAX SATIN TAMPONS, CLOSED END FLUSHABLE APPLICATOR
K002096 · HEB
Procter & Gamble Co.
Obstetrics & Gynecology · 59d
Cleared Sep 08, 2000
RUBBERCARE POLYMER-COATED POWDERED LATEX EXAMINATION GLOVES/GUARDIAN...
K002111 · LYY
Perusahaan Pelindung Getah (M) Sdn Bhd
General Hospital · 58d
Cleared Sep 08, 2000
SUPER 3
K002299 · EJH
Dental Alloy Products, Inc.
Dental · 42d