FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
136057–136080 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 29, 1988
THUMPER MODEL P-1000
K880597 · BYI
Micro Tek Engineering
Anesthesiology · 47d
Cleared Mar 29, 1988
CERULLO SUCTION REGULATOR
K880704 · GCX
Aesculap Instruments Corp.
General Hospital · 36d
Cleared Mar 29, 1988
WAKO(TM) IGA-HA DIRECT
K880803 · CZP
Wako Chemicals USA, Inc.
Immunology · 29d
Cleared Mar 28, 1988
TECNOL LASER SURGICAL MASK
K874894 · FXX
Tecnol New Jersey Wound Care, Inc.
General Hospital · 118d
Cleared Mar 28, 1988
MODIFIED SCHNEIDER-SHILEY PRESSURE MANOMETER
K875322 · KRK
Schneider-Shilley (Usa)
Cardiovascular · 90d
Cleared Mar 28, 1988
MODIFIED SCHNEIDER-SHILEY WIRE TORQUER
K875323 · DQX
Schneider-Shilley (Usa)
Cardiovascular · 90d
Cleared Mar 28, 1988
COLORGENE FLUORESCENT DNA HYBRIDIZATION TEST / CMV
K875367 · GQM
Enzo Biochem, Inc.
Microbiology · 88d
Cleared Mar 28, 1988
OECO MEMBRANE OXYGNE & VAPOR ENRICHER MODEL OE-8
K880044 · CAW
Oxygen Enrichment Company, Ltd.
Anesthesiology · 82d
Cleared Mar 28, 1988
METATECH INTRACRANIAL PRESSURE MONITORING SYSTEM
K880154 · GWM
Metatech Corp.
Neurology · 75d
Cleared Mar 28, 1988
SINGLE PHASE DIAGNOSTIC X-RAY GENERATOR FX 350
K880532 · IZO
Fischer Imaging Corp.
Radiology · 48d
Cleared Mar 28, 1988
PICS-2000
K880822 · JAK
Philips Medical Systems, Inc.
Radiology · 27d
Cleared Mar 28, 1988
SOMATOM PLUS
K880965 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 20d
Cleared Mar 28, 1988
GV 11 (TM), MODEL 9700
K881082 · IPF
Medical Devices, Inc.
Physical Medicine · 14d
Cleared Mar 28, 1988
KINETIC FIBRINOGEN ASSAY
K881150 · GIS
Bio/Data Corp.
Hematology · 11d
Cleared Mar 28, 1988
JOHNSON & JOHNSON FLUFF SPONGE
K881222 · EFQ
Johnson & Johnson Professionals, Inc.
General & Plastic Surgery · 6d
Cleared Mar 25, 1988
MODEL 5050 SURGILASER FOR UROLOGY USE
K871932 · LNK
Lasermatic, Inc.
Gastroenterology & Urology · 311d
Cleared Mar 25, 1988
MODEL 5050 SURGILASER FOR GASTRO-INTESTINAL USE
K871934 · LNK
Lasermatic, Inc.
Gastroenterology & Urology · 311d
Cleared Mar 25, 1988
DISPOSABLE ANGIOGRAPHIC, CONTROL SYRINGE
K873410 · DXT
Blood Gas Supply Co.
Cardiovascular · 213d
Cleared Mar 25, 1988
PHOTIC STIMULATOR MODELS 580-PSCOMP,PSCEEG,PSSTAL
K874136 · GWE
Bio-Logic Systems Corp.
Neurology · 164d
Cleared Mar 25, 1988
MODIFIED SCHNEIDER SHILEY INFLATION SYRINGES
K875324 · DXT
Schneider-Shilley (Usa)
Cardiovascular · 87d
Cleared Mar 25, 1988
MODIFIED SELDINGER INITIAL PUNCTURE INSTRUMENT
K875327 · DRE
Schneider-Shilley (Usa)
Cardiovascular · 87d
Cleared Mar 25, 1988
RSI GLENOID ARCUATE BONE DRILL W/DISP. FLEXI-BITS
K880074 · HSZ
Romano Surgical Instrumentation, Inc.
Orthopedic · 74d
Cleared Mar 25, 1988
TENDON HARVESTER
K880414 · HRX
Concept, Inc.
Orthopedic · 53d
Cleared Mar 25, 1988
VENTREZYME VAST IMMUNO-PEROXIDASE ASSAY
K880547 · DHB
Ventrex Laboratories, Inc.
Immunology · 45d