FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
132073–132096 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 14, 1989
EZ COMPLEMENT C2
K892125 · CZW
Diamedix Corp.
Immunology · 18d
Cleared Apr 14, 1989
EZ COMPLEMENT C3
K892127 · CZW
Diamedix Corp.
Immunology · 18d
Cleared Apr 14, 1989
EZ COMPLEMENT C4
K892129 · DBI
Diamedix Corp.
Immunology · 18d
Cleared Apr 14, 1989
C REACTIVE PROTEIN LIQUID
K892146 · DCK
Ampcor, Inc.
Immunology · 14d
Cleared Apr 13, 1989
PENN-PET SCANNER
K890100 · KPS
Ugm Medical Systems, Inc.
Radiology · 93d
Cleared Apr 13, 1989
DEKNATEL HIGH PRECISION VASCULAR PUNCH(TM)
K890432 · DWS
Deknatel, Inc.
Cardiovascular · 76d
Cleared Apr 13, 1989
PATIENT EXAMINATION GLOVE (LATEX)
K891112 · LYY
Medglove
General Hospital · 42d
Cleared Apr 13, 1989
CURITY DISPOSABLE LATEX GLOVES
K891255 · LYY
Kendall Healthcare Products Co....
General Hospital · 36d
Cleared Apr 13, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K891264 · LYY
Safeskin Corp.
General Hospital · 36d
Cleared Apr 13, 1989
PATIENT EXAMINATION GLOVES (VINYL)
K891356 · LYZ
Pm Gloves, Inc.
General Hospital · 34d
Cleared Apr 13, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K891632 · LYY
Rank Rubber Industries Sdn Bhd
General Hospital · 27d
Cleared Apr 13, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K891639 · LYY
Tak Ent., Inc.
General Hospital · 27d
Cleared Apr 13, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K891884 · LYY
Duflex Products Sdn. Bhd.
General Hospital · 16d
Cleared Apr 12, 1989
SENSODYNE SEALANT DENTIN CONDITIONING SYSTEM
K884533 · KLE
Block Drug Company, Inc.
Dental · 166d
Cleared Apr 12, 1989
D-SCOPE III
K884661 · IYX
Medx, Inc.
Radiology · 156d
Cleared Apr 12, 1989
EBV EARLY ANTIGEN (R+D)
K884829 · JRY
Hillcrest Biologicals
Microbiology · 145d
Cleared Apr 12, 1989
IMMUNOCOMB(TM) TOXOPLASMA IGG ANTIBODY TEST KIT
K885344 · LGD
Orgenics, Ltd.
Microbiology · 105d
Cleared Apr 12, 1989
OCULAR CONNECTION MACHINE(TM)
K890133 · HQE
Innovision Medical, Inc.
Ophthalmic · 90d
Cleared Apr 12, 1989
SHARPLAN MODEL 1050 SEALED-OFF CO2 SURGICAL LASER
K890287 · GEX
Sharplan Lasers, Inc.
General & Plastic Surgery · 83d
Cleared Apr 12, 1989
URIC ACID KIT, CODES 4825400 AND 4825050
K890319 · KNK
American Research Products Co.
Chemistry · 79d
Cleared Apr 12, 1989
REVISED OHMEDA MODULUS II ANESTHESIA GAS MACHINE
K890410 · BSZ
Ohmeda Medical
Anesthesiology · 78d
Cleared Apr 12, 1989
MODEL 611101 CONTRAST INJECTION DEVICE
K890898 · DXT
Medtronic Versaflex, Inc.
Cardiovascular · 49d
Cleared Apr 12, 1989
MODIFIED STOCKERT-SHILEY CAPS MULTI. ROLLER PUMP
K890904 · DWB
Shiley, Inc.
Cardiovascular · 61d
Cleared Apr 12, 1989
SURGICAL FACE MASK-EAR LOOP
K891051 · FXX
Dispomed, Inc.
General Hospital · 44d