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
137833–137856 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 27, 1987
USI BASIC. AG 1050. AG 1090
K873146 · ELC
Cranston Ind., Inc.
Dental · 77d
Cleared Oct 27, 1987
HICKMAN PLASTIC SUBCUTANEOUS PORT
K873213 · LJT
C.R. Bard, Inc.
General Hospital · 74d
Cleared Oct 27, 1987
SINTERLOY
K873373 · EJS
Denpac Corp.
Dental · 64d
Cleared Oct 27, 1987
BAKER TWIN-CUFF INTESTINAL DECOMP/PLICATION TUBE
K873441 · KNT
Bissell Medical Products, Inc.
Gastroenterology & Urology · 61d
Cleared Oct 27, 1987
PULP PEN
K873644 · EAT
The Hygenic Corp.
Dental · 48d
Cleared Oct 27, 1987
COLTENE PRESIDENT JET IMPRESSION MATERIALS SYSTEM
K873671 · EKS
Coltene, Inc.
Dental · 46d
Cleared Oct 27, 1987
#24L SYSTEM
K873878 · EBF
Pentron Corp.
Dental · 35d
Cleared Oct 27, 1987
CM 5000R REMOTE AIRWAY PRESSURE
K873953 · CAP
Canadian Monaghan , Ltd.
Anesthesiology · 29d
Cleared Oct 26, 1987
SMK SLUYTER-MEHTA CANNULAE, RF POLE, POLE,FLEXIBLE
K870028 · GXI
Radionics, Inc.
Neurology · 294d
Cleared Oct 26, 1987
SOPHY SERIES OF NUCLEAR MEDICINE COMPUTER SYSTEMS
K872132 · IXY
Sopha Medical Systems, Inc.
Radiology · 145d
Cleared Oct 26, 1987
INFANT MONITOR, MODEL 2400
K872631 · BZQ
Arvee Medical, Inc.
Anesthesiology · 112d
Cleared Oct 26, 1987
MODEL 7200A WITH PULSE OXIMETRY
K873065 · DQA
Puritan Bennett Corp.
Anesthesiology · 82d
Cleared Oct 26, 1987
GAMBRO BICART SYSTEM
K873155 · FKP
Gambro, Inc.
Gastroenterology & Urology · 77d
Cleared Oct 26, 1987
DISPOSABLE, MANUAL PULMONARY RESUSCITATOR
K873286 · BTM
Hospitak, Inc.
Anesthesiology · 70d
Cleared Oct 26, 1987
ELECTROBLOC TRANS. ELECTRICAL NERVE BLOCK GENERA.
K873357 · GZJ
Th Charters, Inc.
Neurology · 67d
Cleared Oct 26, 1987
NICOLET EXPERT SLEEP/WAKE ANALYSIS SYSTEM
K873535 · GWQ
Nicolet Biomedical Instruments
Neurology · 55d
Cleared Oct 26, 1987
MPG-50 X-RAY GENERATOR
K873544 · IZO
Thomson-Cgr Medical Corp.
Radiology · 55d
Cleared Oct 26, 1987
MODIFIED Q4000 & Q3040 ELECTROCARDIOGRAPH MONITOR
K873584 · DPS
Quinton, Inc.
Cardiovascular · 52d
Cleared Oct 26, 1987
SURGICAL PENCIL/ ELECTROSURGICAL PENCIL
K873595 · GEI
Yuntek International, Inc.
General & Plastic Surgery · 52d
Cleared Oct 26, 1987
ANEUROPLASTIC, ACRYLIC ANEURYOMORRHAPLY MATERIAL
K873688 · JXH
Dentsply Intl.
Neurology · 46d
Cleared Oct 26, 1987
CRANIOPLASTIC, ACRYLIC CRANIOPLASTY MATERIAL
K873689 · GXP
Dentsply Intl.
Neurology · 45d
Cleared Oct 26, 1987
CEDAR(TM) PELVIC CUSHION
K873690 · LWG
Cedar Surgical, Inc.
General & Plastic Surgery · 48d
Cleared Oct 23, 1987
MICROS(TM)
K871995 · FPA
Controlled Release Technologies, Inc.
General Hospital · 150d
Cleared Oct 23, 1987
DHEA-S RIA KIT
K872879 · JKC
Endocrine Associates, Inc.
Chemistry · 94d