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
133009–133032 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 12, 1988
FLO-GARD VP
K884014 · FRN
Baxter Healthcare Corp
General Hospital · 81d
Cleared Dec 12, 1988
TX-7 (TENS) (IC-1107)
K884210 · GZJ
Oms Medical Supplies, Inc.
Neurology · 67d
Cleared Dec 12, 1988
WOODEN SPECTACLE FRAMES
K884272 · HQZ
Woodwave
Ophthalmic · 61d
Cleared Dec 12, 1988
CONTROL SYRINGE
K884497 · FMF
Professional Medical Services
General Hospital · 48d
Cleared Dec 12, 1988
UV AIR STERILIGHT
K884579 · FRA
Allseasons Environmental Control, Inc.
General Hospital · 39d
Cleared Dec 12, 1988
ROLLS 3000 SERIES WHEELCHAIR (YOUTHMOBILE)
K884931 · IOR
Invacare Corp.
Physical Medicine · 14d
Cleared Dec 12, 1988
INVACARE YOUTHMOBILE 5000 SERIES WHEELCHAIR
K884932 · IOR
Invacare Corp.
Physical Medicine · 14d
Cleared Dec 09, 1988
IDS-1600 SAMPLE HANDLING SYSTEM
K883470 · JQW
Baxter Healthcare Corp
Chemistry · 116d
Cleared Dec 09, 1988
ACCUCHEK II FREEDOM(TM) MONITORING SYSTEM
K883817 · CGA
Boehringer Mannheim Corp.
Chemistry · 92d
Cleared Dec 09, 1988
ND:YAG LASER SPECTACLES, MST MODEL #YLS-5
K883839 · KYP
Marlo Surgical Technology
General Hospital · 88d
Cleared Dec 09, 1988
ROCHE REAGENT FOR CHLORIDE
K884013 · CHJ
Roche Diagnostic Systems, Inc.
Chemistry · 78d
Cleared Dec 09, 1988
TOTAL PROTEIN REAGENT KIT FOR ASTRA SYSTEMS
K884225 · CEK
A-Kem, Inc.
Chemistry · 64d
Cleared Dec 09, 1988
AMYLASE REAGENT KIT FOR ASTRA SYSTEMS
K884226 · CJA
A-Kem, Inc.
Chemistry · 64d
Cleared Dec 09, 1988
CALIBRATOR STANDARD KIT FOR ASTRA SYSTEM
K884227 · JIX
A-Kem, Inc.
Chemistry · 64d
Cleared Dec 09, 1988
SURGEON'S GLOVE ACCESSORY
K884417 · LYY
Allied Signal, Inc.
General Hospital · 50d
Cleared Dec 09, 1988
SERUM HCG MICROASSAY
K884430 · DHA
Diamedix Corp.
Chemistry · 49d
Cleared Dec 09, 1988
MODIFIED LSF TOTAL HIP SYSTEM
K884432 · JDI
Implant Technology, Inc.
Orthopedic · 49d
Cleared Dec 09, 1988
STERILE DISPOSABLE ENDOCULAR PROBE
K884456 · GEX
Biophysic Medical, Inc.
General & Plastic Surgery · 46d
Cleared Dec 09, 1988
RUBIN BONE PLANER W/REPLACEABLE BLADE
K884473 · GAC
Neo Contemporary Co.
General & Plastic Surgery · 45d
Cleared Dec 09, 1988
FRANTZ MEDICAL SHARPS COLLECTOR
K884589 · FMF
Franklin Medical USA, Inc.
General Hospital · 36d
Cleared Dec 09, 1988
MODIFIED CEDIA TOTAL T4 ASSAY
K884634 · KLI
Microgenics Corp.
Chemistry · 32d
Cleared Dec 09, 1988
QUALTEX NEUROLOK SURGICAL SPONGE
K884790 · GDY
Deroyal Industries, Inc.
General & Plastic Surgery · 24d
Cleared Dec 08, 1988
MODIFIED IDEIA CHLAMYDIA TEST
K880799 · LJC
Boots-Celltech Diagnostics, Inc.
Microbiology · 283d
Cleared Dec 08, 1988
RETRACTABLE NEEDLE 3CC SYRINGE
K881454 · FMF
Kenmar Medical
General Hospital · 246d