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
131497–131520 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Apr 12, 1989
SPLASH GUARD GOGGLE
K891052 · FXX
Dispomed, Inc.
General Hospital · 44d
Cleared Apr 12, 1989
DENTAL BIB
K891053 · FYB
Dispomed, Inc.
General Hospital · 44d
Cleared Apr 12, 1989
SURGICAL CONE MASK
K891056 · FXX
Dispomed, Inc.
General Hospital · 44d
Cleared Apr 12, 1989
DENTAL GOWN
K891058 · FYA
Dispomed, Inc.
General Hospital · 44d
Cleared Apr 12, 1989
REPOSITIONABLE BITEWING X-RAY FILM HOLDER KIT
K891186 · EHA
Benn Research , Ltd.
Dental · 37d
Cleared Apr 12, 1989
C. ALBICANS SCREEN
K891476 · JXC
Carr-Scarborough Microbiologicals, Inc.
Microbiology · 27d
Cleared Apr 12, 1989
C-5 PALLADIUM BASE DENTAL ALLOY
K891514 · EJT
Macdonald Metals and Ceramics
Dental · 26d
Cleared Apr 12, 1989
C-63 GOLD BAE DENTAL ALLOY
K891517 · EJT
Macdonald Metals and Ceramics
Dental · 26d
Cleared Apr 12, 1989
C-76 GOLD BASE DENTAL ALLOY
K891518 · EJT
Macdonald Metals and Ceramics
Dental · 26d
Cleared Apr 12, 1989
C-86 GOLD BASE DENTAL ALLOY
K891519 · EJT
Macdonald Metals and Ceramics
Dental · 26d
Cleared Apr 12, 1989
C-87 GOLD BASE DENTAL ALLOY
K891520 · EJT
Macdonald Metals and Ceramics
Dental · 26d
Cleared Apr 12, 1989
M-1 GOLD BASE DENTAL ALLOY
K891521 · EJT
Macdonald Metals and Ceramics
Dental · 26d
Cleared Apr 12, 1989
M-4 GOLD BASE DENTAL ALLOY
K891522 · EJT
Macdonald Metals and Ceramics
Dental · 26d
Cleared Apr 12, 1989
M-20 GOLD BASE DENTAL ALLOY
K891523 · EJT
Macdonald Metals and Ceramics
Dental · 26d