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
151153–151176 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 20, 1984
WELLS JOHNSON CO. CHAJ-CHIR-SUCTION TIP
K843188 · JOL
Wells Johnson Co.
General Hospital · 38d
Cleared Sep 20, 1984
ECLIPSE HEART SUPPORT FOR CORONARY ARTER
K843216 · GAD
Biotrac Laboratories
General & Plastic Surgery · 36d
Cleared Sep 20, 1984
ARROW-JOHANS ECG ADAPTOR
K843263 · DQY
Arrow Intl., Inc.
Cardiovascular · 31d
Cleared Sep 20, 1984
SYSTEMATE T-BILI 67212
K843328 · CIG
Em Diagnostic Systems, Inc.
Chemistry · 24d
Cleared Sep 20, 1984
SYSTEMATE D-BILI 67213
K843329 · CIG
Em Diagnostic Systems, Inc.
Chemistry · 24d
Cleared Sep 20, 1984
SYSTEMATE GOT 67208
K843333 · CIT
Em Diagnostic Systems, Inc.
Chemistry · 24d
Cleared Sep 20, 1984
SYSTEMATE GPT 67209
K843334 · CKA
Em Diagnostic Systems, Inc.
Chemistry · 24d
Cleared Sep 20, 1984
RAICHEM CALCIUM REAGENT
K843353 · CIC
Reagents Applications, Inc.
Chemistry · 24d
Cleared Sep 20, 1984
ACID PHOSPHATASE ASSAY KIT
K843380 · CKE
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 23d
Cleared Sep 20, 1984
EMIT 700 AMPHETAMINE ASSAY NEW PRODUCT
K843458 · DKZ
Syva Co.
Toxicology · 15d
Cleared Sep 19, 1984
TRACHEAL TUBE 16 GAUGE-1.65MM-
K832466 · BTO
Erie Medical
Anesthesiology · 421d
Cleared Sep 19, 1984
ACKRAD HYSTEROSALPINGOGRAPHY SET
K842231 · KNA
Ackrad Laboratories
Obstetrics & Gynecology · 106d
Cleared Sep 19, 1984
OB ULTRASOUND LINEAR SCANNER 630
K842261 · HEM
Ge Medical Systems Information...
Obstetrics & Gynecology · 104d
Cleared Sep 19, 1984
AUTOMATIC PATIENT CHAIR PM2000 & A
K842359
Planmeca USA, Inc.
Dental · 89d
Cleared Sep 19, 1984
MEDCOLATOR MODEL GX
K842712 · IPF
Medco Products, Co., Inc.
Physical Medicine · 69d
Cleared Sep 19, 1984
DISPOSABLE TISSUE EFFECT BIOSENSOR-T
K843157 · FLL
Pan Dynamics Medical Corp.
General Hospital · 40d
Cleared Sep 19, 1984
SONIC AID GREEN ULTRASOUND GEL
K843167 · IYO
Wpc Brands, Inc.
Radiology · 37d
Cleared Sep 19, 1984
LOW PRESSURE ALARM FOR OXYGEN CYLINDER
K843212 · BXH
Hospitak, Inc.
Anesthesiology · 35d
Cleared Sep 19, 1984
TOP DISPOSABLE SPINAL NEEDLE
K843313 · BSP
Top Surgical Manufacturers Co.
Anesthesiology · 26d
Cleared Sep 19, 1984
ELECTROSTIM 380
K843488 · IPF
Micron Instruments, Inc.
Physical Medicine · 13d
Cleared Sep 18, 1984
BARD CO2 SURGICAL LASER SYS SLS-50/100
K834166 · GEX
C.R. Bard, Inc.
General & Plastic Surgery · 308d
Cleared Sep 18, 1984
INFUSE-A-PORT HEPARIN LOCK MAINT KIT
K840481 · LJT
Infusaid Corp.
General Hospital · 225d
Cleared Sep 18, 1984
OMNISTIM II COMBIN. THERAPY SYS
K843351 · IMG
Physio Technology, Inc.
Physical Medicine · 22d
Cleared Sep 18, 1984
OMNISOUND THERAPY UNIT
K843372 · IMI
Physio Technology, Inc.
Physical Medicine · 21d