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
164401–164424 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 09, 1981
IMMUNOLOGY CONTROL SERUM
K810056 · DEW
Icl Scientific
Immunology · 27d
Cleared Feb 09, 1981
SCRIPPSERA ANA REFERENCE CONTROL SERA
K810081 · DHN
Scripps-Miles, Inc.
Immunology · 27d
Cleared Feb 09, 1981
CONTROL SERUMS FOR NONTREPONEMAL TEST
K810119 · GMP
Hillside Acres, Inc.
Toxicology · 24d
Cleared Feb 09, 1981
INERTIAL EXTENSILIZER CHIRO. ADJ. TABLE
K810125 · INQ
The Inertial Corp.
Physical Medicine · 21d
Cleared Feb 09, 1981
SCRIPPSYSTEM RHEUMATOID FACTOR LATEX KIT
K810141 · DHR
Scripps-Miles, Inc.
Immunology · 19d
Cleared Feb 09, 1981
VENTILATORY EFFORT MONITOR
K810153 · FLS
Medicon, Inc.
Anesthesiology · 19d
Cleared Feb 09, 1981
WILLIAMS OESOPHAGEAL VARICES INJECT TUBE
K810180 · FED
Keymed, Inc.
Gastroenterology & Urology · 18d
Cleared Feb 09, 1981
MECRON CANCELLOUS CANNULATED BONE SCREWS
K810205 · HWC
Serrano Intl.
Orthopedic · 14d
Cleared Feb 09, 1981
ARGYLE ROB-NELS
K810216 · KOD
Sherwood Medical Co.
Gastroenterology & Urology · 13d
Cleared Feb 09, 1981
SCRIPPSERA THEUMATOID FACTOR REFER. CNTL
K810221 · DHR
Scripps-Miles, Inc.
Immunology · 13d
Cleared Feb 09, 1981
SLE ANTI-N-DNA LATEX TEST
K810226 · DHC
Icl Scientific
Immunology · 13d
Cleared Feb 09, 1981
SCEPTOR SYSTEM AUTOMATED MODEL 216
K810229 · JTC
Bd Becton Dickinson Vacutainer...
Microbiology · 13d
Cleared Feb 09, 1981
DISPOSABLE PILLOW
K810264 · KME
Anago, Inc.
General Hospital · 7d
Cleared Feb 09, 1981
FEMORAL CANAL BRUSH
K810267 · LXH
Richard'S Medical Equip., Inc.
Orthopedic · 39d
Cleared Feb 06, 1981
HYDROPHILIC COATED CATHETER
K810023 · BSY
Bd Becton Dickinson Vacutainer...
Anesthesiology · 32d
Cleared Feb 06, 1981
CURITY CURAD BANDAGES
K810126 · KGX
The Kendal Co.
General & Plastic Surgery · 18d
Cleared Feb 06, 1981
ENDAB CORTISOL KIT
K810192 · CGR
Immunotech Corp.
Toxicology · 14d
Cleared Feb 05, 1981
PACEMAKER PATIENT MGMT. SYSTEM
K801810 · DQK
Siemens Elema AB
Cardiovascular · 190d
Cleared Feb 05, 1981
LEKSELL STEREOTACTIC SYSTEM
K802140 · IWY
Downs Surgical , Ltd.
Radiology · 154d
Cleared Feb 05, 1981
IMPLANTABLE VENTRICULAR-INHIBITED CARDI
K802175
Telectronics, Inc.
Cardiovascular · 149d
Cleared Feb 05, 1981
SIEMENS-ELEMA PULSE GENERATOR 678
K802864 · DXY
Siemens Elema AB
Cardiovascular · 85d
Cleared Feb 05, 1981
SEBESTYEN IRRIGATING CONTACT LENS
K802927 · HJI
Cooper Medical Devices Corp.
Ophthalmic · 78d
Cleared Feb 05, 1981
LANDERS CONTACT LENS
K802971 · HJI
Cooper Medical Devices Corp.
Ophthalmic · 76d
Cleared Feb 05, 1981
CONPHAR EYE PROTECTOR
K803145 · HMP
Conphar, Inc.
General & Plastic Surgery · 55d