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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
96097–96120 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 09, 1996
HEELBO ICU 911 BLAZER SLEEVED JACKET
K963237 · FMQ
Heelbo, Inc.
General Hospital · 51d
Cleared Oct 09, 1996
SLEEPER JACKET/HOUDINI SAFETY SLEEPER
K963457 · FMQ
Skil-Care Corp.
General Hospital · 36d
Cleared Oct 09, 1996
ROLL BELT
K963460 · FMQ
Skil-Care Corp.
General Hospital · 36d
Cleared Oct 08, 1996
OHMEDA EXCEL DRAW-OVER MILITARY VAPORIZER SYSTEM
K946127 · BSZ
Ohmeda Medical
Anesthesiology · 663d
Cleared Oct 08, 1996
RACZ EPIDURAL CATHETER
K954584 · BSO
Medic Evaluation Devices &...
Anesthesiology · 372d
Cleared Oct 08, 1996
PERNECZKY CLIP APPLIER/REMOVER
K954658 · HCI
Von Zeppelin GmbH
Neurology · 364d
Cleared Oct 08, 1996
RESCUE BREATHER
K955520 · CBP
International Safety, Inc.
Anesthesiology · 309d
Cleared Oct 08, 1996
CELL DYN 3500 MULTI-PARAMETER AUTOMATED HEMATOLOGY ANALYZER (MODIFICATION)
K955715 · GKZ
Abbott Laboratories
Hematology · 313d
Cleared Oct 08, 1996
ZIMMER ZIRCONIA CERAMIC FEMORAL HEAD
K955877 · LZO
Zimmer, Inc.
Orthopedic · 287d
Cleared Oct 08, 1996
CARDIOVIEW TRANSTELEPHONIC SOFTWARE
K955891 · DPS
Micromedical, Inc.
Cardiovascular · 284d
Cleared Oct 08, 1996
VIDAMED TUNA (TRANSURETHRAL NEEDLE ABLATION) SYSTEM
K960918 · GEI
Vidamed, Inc.
General & Plastic Surgery · 216d
Cleared Oct 08, 1996
ETEST SUBMISSION FOR AMOXICILLIN
K960991 · JWY
Ab Biodisk
Microbiology · 211d
Cleared Oct 08, 1996
DELTA HIP PROSTHESIS
K961378 · LWJ
Zimmer, Inc.
Orthopedic · 181d
Cleared Oct 08, 1996
HP CATHSTATION - MODEL M1264B
K961401 · DPS
Hewlett-Packard Co.
Cardiovascular · 180d
Cleared Oct 08, 1996
HEARTPORT THORACIC SURGICAL TROCARS: (TOST-4-3, TOSTL-6-3, TON-4-2 AND TONL-6-2
K961463 · GCJ
Heartport, Inc.
General & Plastic Surgery · 174d
Cleared Oct 08, 1996
APEX UNIVERSAL IRRIGATION SYSTEM & TWO-CONNECTION TUBING SET
K961590 · HRX
Linvatec Corp.
Orthopedic · 167d
Cleared Oct 08, 1996
DEROYAL INDUSTRIES, INC. ELECTROSURGICAL CAUTERY PENCIL
K961647 · GEI
Deroyal Industries, Inc.
General & Plastic Surgery · 161d
Cleared Oct 08, 1996
AIR-MEDEX I
K961769 · FNM
Robert Gold Assoc.
General Hospital · 153d
Cleared Oct 08, 1996
GLASS SYRINGE
K962042 · FMF
Ispg, Inc.
General Hospital · 133d
Cleared Oct 08, 1996
ESOPHAGEAL INTUBATION DETECTOR
K962098 · BTR
Kirk Specialty Systems
Anesthesiology · 132d
Cleared Oct 08, 1996
SCANTIBODIES LABORATORY TSH IMMUNORADIOMETRIC ASSAY (IRMA)(COATED TUBE...
K962464 · JLW
Scantibodies Laboratory, Inc.
Chemistry · 105d
Cleared Oct 08, 1996
Q-TIPS, FAICHNEY, PRIVATE LABEL
K962497 · FLL
Faichney Medical Co.
General Hospital · 104d
Cleared Oct 08, 1996
APEX FINDER MODELS 7005
K962803 · LQY
Sybron Dental Specialties, Inc.
Dental · 82d
Cleared Oct 08, 1996
OOLITT TONGUE CLEANER, REGULAR LOW RIPPLE/SPECIAL HIGH RIPPLE/LOW RIPPLE...
K962941 · LCN
Deep Trading Corp.
Dental · 71d