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
101593–101616 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 07, 1995
STORZ DP4101 BASIC I/A PACK
K953078 · HQC
Storz Instrument Co.
Ophthalmic · 35d
Cleared Aug 07, 1995
LIMELIGHT
K953079 · EJK
Pulpdent Corp.
Dental · 35d
Cleared Aug 07, 1995
POLYKOTE
K953299 · LYY
Intl. Trade Management Co.
General Hospital · 24d
Cleared Aug 07, 1995
OPTX 20/20
K953413 · HQY
Neoptx, Inc.
Ophthalmic · 18d
Cleared Aug 07, 1995
CURASOL GEL WOUND DRESSING
K953450 · MGQ
Dpt Laboratories, Ltd.
General & Plastic Surgery · 20d
Cleared Aug 07, 1995
SUNGLASSES (NON-PRESCRIPTION)
K953473 · HQY
Cbi Dist.
Ophthalmic · 14d
Cleared Aug 04, 1995
AI-PHOTODIAGNOSTIC
K940004 · CIB
Pharmarceutical Discovery Corp.
Chemistry · 578d
Cleared Aug 04, 1995
RUBELLA IGG ELISA TEST
K941624 · LFX
Gull Laboratories, Inc.
Microbiology · 487d
Cleared Aug 04, 1995
J & J I-330 SERIES PHYSIOLOGICAL MONITORING & BIOFEEDBACK INSTUMENT AND USE...
K945826 · HCC
Medical Device Inspection Co., Inc.
Neurology · 248d
Cleared Aug 04, 1995
VITALOGRAPH MODEL 2120
K946075 · BZG
Vitalograph, Inc.
Anesthesiology · 242d
Cleared Aug 04, 1995
BALANCE MANAGER
K946229 · KHX
Neurocom International, Inc.
Physical Medicine · 225d
Cleared Aug 04, 1995
V. MUELLER OBSTETRICAL (OB) FORCEPS
K951529 · HDA
Baxter Healthcare Corp
Obstetrics & Gynecology · 123d
Cleared Aug 04, 1995
URINARY DRAINAGE BAG
K951597 · EYZ
Key Medical Services, Inc.
Gastroenterology & Urology · 119d
Cleared Aug 04, 1995
ELECTRONIC LAPAROFLATOR
K951694 · HIF
KARL STORZ Endoscopy-America, Inc.
Obstetrics & Gynecology · 114d
Cleared Aug 04, 1995
ACS POWERBASE GUILDING CATHETER
K952205 · DQY
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 86d
Cleared Aug 04, 1995
TOCO TRANSDUCER
K952579 · HFM
Scientific Device Manufacturer, LLC
Obstetrics & Gynecology · 60d
Cleared Aug 04, 1995
IL TEST CK-MB
K952646 · CGS
Instrumentation Laboratory CO
Chemistry · 56d
Cleared Aug 04, 1995
SAS SHIGELLA DYSENTERIAE GROUP A (1-7) ANTISERUM
K953316 · GNB
Sa Scientific, Inc.
Microbiology · 22d
Cleared Aug 04, 1995
SAS SHIGELLA DYSENTERIAE TYPE 7 ANTISERUM
K953317 · GNB
Sa Scientific, Inc.
Microbiology · 22d
Cleared Aug 04, 1995
SAS SHIGELLA DYSENTERIAE TYPE 6 ANTISERUM
K953318 · GNB
Sa Scientific, Inc.
Microbiology · 22d
Cleared Aug 04, 1995
SAS SHIGELLA DYSENTERIAE TYPE 5 ANTISERUM
K953319 · GNB
Sa Scientific, Inc.
Microbiology · 22d
Cleared Aug 04, 1995
SAS SHIGELLA DYSENTERIAE TYPE 4 ANTISERUM
K953320 · GNB
Sa Scientific, Inc.
Microbiology · 22d
Cleared Aug 04, 1995
SAS SHIGELLA DYSENTERIAE TYPE 3 ANTISERUM
K953321 · GNB
Sa Scientific, Inc.
Microbiology · 22d
Cleared Aug 02, 1995
HARVEY CHEMICLAVE EC5000, EC5500, EC6000 STERILIZERS
K943654 · MLR
Mdt Biologic Co.
General Hospital · 370d