FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
100057–100080 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 30, 1996
ARIA CPAP SYSTEM
K953341 · BZD
Respironics, Inc.
Anesthesiology · 266d
Cleared Jan 30, 1996
MLI INTERFERENCE SCREW
K953350 · HWC
Medicinelodge, Inc.
Orthopedic · 197d
Cleared Jan 30, 1996
ULTRACK TOTAL KNEE SYSTEM
K953439 · JWH
Wrightmedicaltechnologyinc
Orthopedic · 193d
Cleared Jan 30, 1996
THROMBELASTOGRAPH COAGULATION ANALYZER 3000S
K954437 · GKP
Haemoscope Corp.
Hematology · 130d
Cleared Jan 30, 1996
STRYKER SAGITTAL SAW ATTACHMENT
K954483 · GFA
Stryker Instruments
General & Plastic Surgery · 125d
Cleared Jan 30, 1996
DRYSIDE NEISSERIA
K954784 · LTS
Difco Laboratories, Inc.
Microbiology · 105d
Cleared Jan 30, 1996
VENIPUNCTURE KIT
K954823 · FPA
Winfield Industries
General Hospital · 102d
Cleared Jan 30, 1996
MERCURY CPR (COMPLETE PERSONAL RESUSCIATOR) BAG WITH EXPANDABLE RESERVOIR
K954866 · BTM
Mercury Medical
Anesthesiology · 98d
Cleared Jan 30, 1996
HM-CAP CONTROL PANEL
K954926 · LYR
E-Z-Em, Inc.
Microbiology · 96d
Cleared Jan 30, 1996
HEAT & MOISTURE EXCHANGER
K955008 · BYD
Intertech Resources, Inc.
Anesthesiology · 90d
Cleared Jan 30, 1996
4C PLUS COULTER CELL CONTROL
K955016 · JPK
Coulter Corp.
Hematology · 89d
Cleared Jan 30, 1996
TRIP NGS & SIGMOID CATHETER PHI SLIDE CALCULATOR
K955018 · FFT
Instrumentarium Corp.
Gastroenterology & Urology · 89d
Cleared Jan 30, 1996
BENZODIAZEPINES BY REMEDI HS
K955116 · LAA
Bio-Rad
Toxicology · 82d
Cleared Jan 30, 1996
NEUTRALECT ADULT STANDARD, RETURN (REM) & PAEDIATRIC ELECTROSURGERY PLATE...
K955261 · GEI
Msb , Ltd.
General & Plastic Surgery · 82d
Cleared Jan 30, 1996
PQ-2000+ COMPUTED TOMOGRAPHY X-RAY SYSTEM
K955268 · JAK
Philips Medical Systems (Cleveland),...
Radiology · 74d
Cleared Jan 30, 1996
MICRO-SEAL ACETABULAR SYSTEM
K955271 · LPH
Whiteside Instruments
Orthopedic · 76d
Cleared Jan 30, 1996
OLYMPIC SMART SCALE MODEL 50/50RA
K955357 · FRW
Olympic Medical Corp.
General Hospital · 99d
Cleared Jan 30, 1996
JOHNSON & JOHNSON AUSTIN MOORE STEM
K955385 · KWL
Johnson & Johnson Professionals, Inc.
Orthopedic · 67d
Cleared Jan 30, 1996
SWIFT INFANT OXYGEN HOOD-REUSABLE (MODIFICATION)
K955482 · FOG
Advantage Medical Services, Inc.
Anesthesiology · 90d
Cleared Jan 30, 1996
INTERPORE IMZ CYL IMPLANT & CYL HEX IMPLT
K955492 · DZE
Interpore Intl.
Dental · 60d
Cleared Jan 30, 1996
ABUTMENT RETRIEVAL KIT
K955697 · DZE
Nobelpharma USA, Inc.
Dental · 47d
Cleared Jan 30, 1996
TREBAY MICRODEBRIDER SYSTEM
K955704 · EQJ
Trebay Medical Corp.
Ear, Nose, Throat · 46d
Cleared Jan 29, 1996
MANUAL MASSAGE ROLLER
K936312 · LYG
Mckenna & Cuneo
Physical Medicine · 794d
Cleared Jan 29, 1996
IL TEST ACID PHOSPHATASE
K943366 · CKB
Instrumentation Laboratory CO
Chemistry · 565d