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
170449–170472 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 17, 1978
PRESSURE INFUSION CUFF
K781556 · DXN
Abbott Laboratories
Cardiovascular · 36d
Cleared Oct 17, 1978
24-HOUR URINE COLLECTION COOLING WRAP
K781557 · FMH
Sage Products, Inc.
General Hospital · 36d
Cleared Oct 17, 1978
RIA DIAG. TEST KIT FOR INDEXING THYROX.
K781560 · CEC
Nuclear Diagnostics, Inc.
Chemistry · 36d
Cleared Oct 17, 1978
NORMAL HEMATOLOGY CONTROL UNASSAYED
K781572 · JPK
Ortho Diagnostics, Inc.
Hematology · 33d
Cleared Oct 17, 1978
ABNORMAL HEMATOLOGY CONTROL UNASSAYED
K781573 · JPK
Ortho Diagnostics, Inc.
Hematology · 33d
Cleared Oct 17, 1978
SURGICAL LIGHT 22 SERIES
K781581 · FQP
American Sterilizer Co.
General & Plastic Surgery · 32d
Cleared Oct 17, 1978
RIA CONTROLS
K781593 · JJY
Dade, Baxter Travenol Diagnostics, Inc.
Chemistry · 29d
Cleared Oct 17, 1978
TECHNICON AUTOSLIDE STAINING/PROCESSING
K781598 · KPA
Technicon Instruments Corp.
Hematology · 29d
Cleared Oct 17, 1978
I-ESTRIOL TEST SET
K781599 · CGI
Wien Laboratories, Inc.
Hematology · 29d
Cleared Oct 17, 1978
STREP-TEX
K781607 · GTZ
Burroughs Wellcome Co.
Immunology · 29d
Cleared Oct 17, 1978
BACK TRAC
K781647 · HST
Tech Engineering, Inc.
Neurology · 20d
Cleared Oct 17, 1978
TERRY KERATOMETER
K781650 · HJA
Clifford M. Terry, M.C.
Ophthalmic · 20d
Cleared Oct 17, 1978
PROJECTOR, ACCU-CHART ACUITY
K781658 · HOS
Bausch & Lomb, Inc.
Ophthalmic · 19d
Cleared Oct 17, 1978
THERMOMETER, DIGITAL ELEC. MODEL 4755
K781661 · FLL
British Aerospace, Inc.
General Hospital · 18d
Cleared Oct 17, 1978
MAXI-CAMERA 535
K781673 · IYX
General Electric Co.
Radiology · 14d
Cleared Oct 17, 1978
X-RAY STAND, PORTABLE
K781676 · IZL
General X-Ray, Inc.
Radiology · 18d
Cleared Oct 17, 1978
PHIPIOLOGICAL SYNCHRONIZER PART#205
K781681 · IXQ
Brattle Instrument Corp.
Radiology · 15d
Cleared Oct 16, 1978
OXYGEN CONCENTRATOR
K781300 · CAW
Bendix Instruments & Life Support Div
Anesthesiology · 80d
Cleared Oct 16, 1978
DISPOSABLE INCENTIVE SPIROMETER
K781394 · CCQ
Inhal-O-Tech Medical Plastic
Anesthesiology · 63d
Cleared Oct 16, 1978
PATIENT CIRCUIT MANIFOLD
K781485 · CAF
Bourns Medical Systems, Inc.
Anesthesiology · 49d
Cleared Oct 16, 1978
NEBULIZER/HUMIDIFIER MODEL EH 147B
K781591 · KFZ
Mistogen Equipment Co.
Anesthesiology · 28d
Cleared Oct 15, 1978
MONITOR, HEART RATE
K781166 · DRT
Cybernetic Medical, Inc.
Cardiovascular · 95d
Cleared Oct 15, 1978
METER, FLOW, PEAK
K781224 · BZH
Projects IN Health
Anesthesiology · 90d
Cleared Oct 13, 1978
NURITE II, SINGLE
K781683 · GZJ
Bio-Medical Systems Corp.
Neurology · 11d