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
145777–145800 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 12, 1985
L.E.D. GOGGLES, MODEL 580-LEDGOG
K852533 · GWE
Bio-Logic Systems Corp.
Neurology · 181d
Cleared Dec 11, 1985
PRESSURE TRIGGER MOD OF SMEC INTRA-AORT
K840367 · DSP
Smec, Inc.
Cardiovascular · 684d
Cleared Dec 11, 1985
CARDIORATER CR 51
K853673 · DRT
Cardiac Recorders, Ltd.
Cardiovascular · 98d
Cleared Dec 11, 1985
ARTERIAL/VENOUS SAMPLE LINE BOS-CMSL
K853950 · DTL
American Bentley
Cardiovascular · 77d
Cleared Dec 11, 1985
PALL EC PLUS 3LPM MAX. FILTER W/SLEEVE
K853987 · DTM
Pall Biomedical Products Co.
Cardiovascular · 75d
Cleared Dec 11, 1985
MGA 2000 GAS ANALYSER
K854076 · DOP
Airspec , Ltd.
Toxicology · 65d
Cleared Dec 11, 1985
KALLESTAD QUANTIMETRIC PLUS IGG REAGENT KIT
K854483 · KTO
Kallestad Laboratories, Inc.
Immunology · 34d
Cleared Dec 11, 1985
DELTA-LITE CASTING RESIN
K854554 · LGF
Johnson & Johnson Professionals, Inc.
Orthopedic · 28d
Cleared Dec 11, 1985
EMERSON MODEL 3MV-OAA ALARM MODULE
K854799 · CCL
J. H. Emerson Co.
Anesthesiology · 9d
Cleared Dec 10, 1985
MEDAJET XL - JET INJECTOR
K850754 · KZE
Mada Medical Products, Inc.
General Hospital · 288d
Cleared Dec 10, 1985
MA-400 EMB FEEDBACK DEVICE
K853806 · HCC
Spectral Data Systems
Neurology · 90d
Cleared Dec 10, 1985
EASY EYES TM LENS CARRYING CASE
K853870 · HPX
Applied Laboratories, Inc.
Ophthalmic · 84d
Cleared Dec 10, 1985
QUANTIMETRIX BIURET SERUM TOTAL PROTEIN ASSAY KIT
K853930 · CEK
Quantimetrix Corp.
Chemistry · 77d
Cleared Dec 10, 1985
MODEL 210 INFUSION PUMP
K854073 · FRN
Avi, Inc.
General Hospital · 67d
Cleared Dec 10, 1985
MODEL 200 INFUSION PUMP
K854074 · FRN
Avi, Inc.
General Hospital · 67d
Cleared Dec 10, 1985
STERILE SALINE SOLUTION
K854155 · KMJ
I M, Inc.
General Hospital · 60d
Cleared Dec 10, 1985
PHARMASEAL SCRUB CARE-SURGICAL SCRUB BRUSH SPONGES
K854232 · GEC
American Pharmaseal Div. Ahsc
General & Plastic Surgery · 50d
Cleared Dec 10, 1985
CHURCHILL-HS SUSPENDED VENTED IV SET
K854627 · FPA
Churchill Corp.
General Hospital · 22d
Cleared Dec 10, 1985
CHURCHILL-H EXTENSION TUBE
K854629 · FPK
Churchill Corp.
General Hospital · 22d
Cleared Dec 10, 1985
CHURCHILL-HS SUSPENDED NON-VENTED IV SET
K854630 · FPA
Churchill Corp.
General Hospital · 22d
Cleared Dec 10, 1985
CHURCHILL-HE VENTED IV SET
K854636 · FPA
Churchill Corp.
General Hospital · 21d
Cleared Dec 10, 1985
MCARTHUR MICROSCOPE PLASTIC VERSION WITH ACC.
K854735 · IBJ
Portable Medical Laboratories, Inc.
Pathology · 15d
Cleared Dec 09, 1985
FLUID MANAGEMENT SYSTEM
K852645 · FRN
Haemonetics Corp.
General Hospital · 171d
Cleared Dec 09, 1985
MEDILOG M6
K852892 · DSI
Oxford Medilog, Inc.
Cardiovascular · 153d