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
78337–78360 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 28, 2001
BIPAP PRO BI-LEVEL SYSTEM
K011714 · BZD
Respironics, Inc.
Anesthesiology · 24d
Cleared Jun 28, 2001
GOVAN+ WHEELCHAIR AND DOCKING ACCESSORY
K011752 · IOR
Accufast, Inc.
Physical Medicine · 22d
Cleared Jun 28, 2001
MODIFICATION TO PLEURX PLEURAL CATHETER AND DRAINAGE KITS
K011831 · DWM
Denver Biomedical, Inc.
Anesthesiology · 16d
Cleared Jun 27, 2001
ORTHOGENESIS LPS SYSTEM
K003182 · JWH
Depuy, Inc.
Orthopedic · 259d
Cleared Jun 27, 2001
EMS 3000
K010745 · IPF
Dan Med, Inc.
Physical Medicine · 106d
Cleared Jun 27, 2001
SIDEPORT PINCH CLAMP DEVICE
K010888 · FPA
Medivice Systems, Ltd.
General Hospital · 96d
Cleared Jun 27, 2001
SYNTHES STERNAL FIXATION SYSTEM
K010943 · JDQ
Synthes (Usa)
Orthopedic · 90d
Cleared Jun 27, 2001
CYPRESS SYSTEM
K010950 · IYO
Acuson Corp.
Radiology · 90d
Cleared Jun 27, 2001
A-LINE AEP MONITOR
K010965 · OLW
Alaris Medical Systems, Inc.
Neurology · 86d
Cleared Jun 27, 2001
LANGHAM OCULAR BLOOD FLOW (OBF) TONOGRAPH/TONOMETER MODEL 201
K010998 · HKX
Langham Ophthalmic Technologies
Ophthalmic · 85d
Cleared Jun 27, 2001
SYNTHES (USA) MEDIUM EXTERNAL FIXATION SYSTEM
K011034 · KTT
Synthes (Usa)
Orthopedic · 83d
Cleared Jun 27, 2001
EASYBELL
K011075 · FCG
Biopsybell S.A.S.
Gastroenterology & Urology · 79d
Cleared Jun 27, 2001
CT/MASTER, VERSION 1.0
K011180 · JAK
Columbia Scientific, Inc.
Radiology · 71d
Cleared Jun 27, 2001
RESTORE-PF VIC
K011295 · EBF
First Scientific Limited
Dental · 58d
Cleared Jun 27, 2001
SMITH AND NEPHEW 5.00MM ABSORBABLE POLYMER ANCHOR
K011299 · MAI
Smith & Nephew, Inc.
Orthopedic · 58d
Cleared Jun 27, 2001
MODIFICATION TO EXCITE
K011490 · KLE
Ivoclar North America, Inc.
Dental · 43d
Cleared Jun 27, 2001
EBI XFIX ACCESS PELVIC FIXATOR
K011697 · KTT
Ebi, L.P.
Orthopedic · 26d
Cleared Jun 27, 2001
NPAC EAR THERMOMETER MODEL TD 402
K011704 · FLL
Norm Pacific Automation Corp.
General Hospital · 26d
Cleared Jun 27, 2001
KEYST0NE MEDICAL PICC CATHETER
K011860 · FOZ
Keystone Medical
General Hospital · 13d
Cleared Jun 26, 2001
Y2000 MANUAL RESUSCITATOR, MODEL RUGU01/RUG02 AND RUGH01/RUGH02
K003927 · BTM
Cheen Houng Ent. Co. , Ltd.
Anesthesiology · 188d
Cleared Jun 26, 2001
SYNGO MULTIMODALITY WORKSTATION
K010938 · LLZ
Siemens Medical Solutions USA, Inc.
Radiology · 89d
Cleared Jun 26, 2001
MEROCEL CORNELL LID AND LASH GUARD, MEROCEL AND KEROCEL OPHTHALMIC SPONGES
K011191 · HOZ
Medtronic Xomed, Inc.
Ophthalmic · 68d
Cleared Jun 26, 2001
MANAN SPRITACRE SPINAL NEEDLES
K011209 · BSP
Manan Medical Products, Inc.
Anesthesiology · 68d
Cleared Jun 26, 2001
HARD RELINER
K011277 · EBI
S & C Polymer GmbH
Dental · 61d