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
81625–81648 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 25, 2000
HEMOFEEL-CH, MODELS CH-0.35L, CH-0.6L, CH-1.0L
K994198 · KDI
Toray Industries (America), Inc.
Gastroenterology & Urology · 256d
Cleared Aug 24, 2000
VEINLASE, MODEL E50-K8-B5, SPECTRUM K8, MODEL E50-K8-B9
K000158 · GEX
Fisma, Inc.
General & Plastic Surgery · 218d
Cleared Aug 24, 2000
VAPOTHERM, MODEL 2000I
K000401 · BTT
Vapotherm, Inc.
Anesthesiology · 199d
Cleared Aug 24, 2000
CHROMOSTREAK
K000718 · JSN
Novamed , Ltd.
Microbiology · 174d
Cleared Aug 24, 2000
ODONTOSURGE 3
K001560 · EKZ
Odonto-Wave
Dental · 97d
Cleared Aug 24, 2000
LIFESITE HEMODIALYSIS ACCESS SYSTEM/CANNULA EXCHANGE, MODEL LHAS14120 &...
K001633 · MSD
Vasca, Inc.
Gastroenterology & Urology · 90d
Cleared Aug 24, 2000
C-REACTIVE PROTEIN ANTISERUM KIT
K001636 · DCK
The Binding Site, Ltd.
Immunology · 86d
Cleared Aug 24, 2000
MODIFICATION TO INTUITIVE SURGICAL STEREO VIEW ENDOSCOPIC SYSTEM
K001666 · GCJ
Intuitive Surgical, Inc.
General & Plastic Surgery · 85d
Cleared Aug 24, 2000
SYNTHES SACRAL BAR SYSTEM
K001720 · JDW
Synthes (Usa)
Orthopedic · 79d
Cleared Aug 24, 2000
HEDROCEL REVISION CUP, MODEL 02-2YY-ZZZZ
K001759 · JDI
Implex Corp.
Orthopedic · 76d
Cleared Aug 24, 2000
ANTERIOR CERVICAL PLATE SYSTEM
K001847 · KWQ
Encore Orthopedics, Inc.
Orthopedic · 66d
Cleared Aug 24, 2000
HEMOSTATIX THERMAL SCALPEL SYSTEM - #12 BLADE
K002021 · GEI
Gyrus Ent LLC
General & Plastic Surgery · 52d
Cleared Aug 24, 2000
HI-TORQUE WHISPER LS GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, HI-TORQUE...
K002206 · DQX
Guidant Corp.
Cardiovascular · 34d
Cleared Aug 24, 2000
SUPER 1
K002298 · EJH
Dental Alloy Products, Inc.
Dental · 27d
Cleared Aug 24, 2000
MODIFIED TO MODULAR FR SEVERE BONE LOSS TRAUMA
K002324 · JDI
Sulzermedica
Orthopedic · 24d
Cleared Aug 24, 2000
MODIFICATION TO AXYA MEDICAL, INC. BONE ANCHOR SYSTEM AND KIT (BAK)
K002435 · GAW
Axya Medical, Inc.
General & Plastic Surgery · 15d
Cleared Aug 23, 2000
3M COMPLY 1249 LIQUID PERACETIC ACID CHEMICAL INDICATOR
K000355 · JOJ
Minnesota Mining and Mfg. Co.
General Hospital · 201d
Cleared Aug 23, 2000
OFFICE BASED ANESTHESIA MACHINE, MODEL OBA-1
K000859 · BSZ
Charles A. Smith
Anesthesiology · 159d
Cleared Aug 23, 2000
DATEX-OHMEDA COMPACT AIRWAY MODULE M-CAIOVX AND M-COVX (VERSION 01) AND...
K001814 · CCK
Datex-Ohmeda
Anesthesiology · 69d
Cleared Aug 23, 2000
CHRONALCO I.D.CDT (CARBOHYDRATE DEFICIENT TRANSFERRIN) ASSAY
K001943 · NAO
Sangui Biotech, Inc.
Chemistry · 58d
Cleared Aug 23, 2000
RENDER-PLAN 3-D 4.00 & PRECISE-PLAN 1.0
K002240 · MUJ
Precision Therapy Intl., Inc.
Radiology · 30d
Cleared Aug 23, 2000
PALM PUMP
K002434 · MEA
Sorenson Medical, Inc.
General Hospital · 14d
Cleared Aug 23, 2000
CECILIA PENGUIN MULTI-USE THERMOMETER, MODEL HP-ETO9999
K993950 · FLL
Nien Made Electrnics Corp.
General Hospital · 275d
Cleared Aug 22, 2000
BRACHYSEED
K000475 · KXK
Draximage, Inc.
Radiology · 189d