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
127297–127320 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 08, 1990
METAL URETERAL BASKET STONE DISLODGER
K896992 · FFL
Annex Medical, Inc.
Gastroenterology & Urology · 59d
Cleared Feb 08, 1990
COULTER PHOSPHORUS REAGENT
K900215 · CEO
Coulter Corp.
Chemistry · 22d
Cleared Feb 08, 1990
COULTER ALP (ALK PHOS) REAGENT
K900216 · CJE
Coulter Corp.
Chemistry · 22d
Cleared Feb 07, 1990
HP SONOS 500 AND SONOS 1000 ULTRA. IMAGING SYSTEM
K896435 · DPT
Hewlett-Packard Co.
Cardiovascular · 90d
Cleared Feb 06, 1990
ADULT RESECTOSCOPE
K890328 · HIH
Circon Video
Obstetrics & Gynecology · 379d
Cleared Feb 06, 1990
GRANITEC P2 AND GRANITEC G2 DENTAL CEMENTS
K894953 · EMA
Confi-Dental Products Co.
Dental · 186d
Cleared Feb 06, 1990
HOMEPUMP (DISP. ELASTOMERIC INFUSION DEVICE)
K896546 · FRN
Block Medical, Inc.
General Hospital · 81d
Cleared Feb 06, 1990
UNIVERSAL POOLE SUCTION TUBE
K896556 · GCX
Westmark, Sterile Packing Systems,...
General Hospital · 81d
Cleared Feb 06, 1990
YANKAUER SUCTION TUBE-FLEXIBLE TYPE
K896557 · GCX
Westmark, Sterile Packing Systems,...
General Hospital · 81d
Cleared Feb 06, 1990
YANKAUER SUCTION TUBE-RIGID TYPE
K896558 · GCX
Westmark, Sterile Packing Systems,...
General Hospital · 81d
Cleared Feb 06, 1990
STOPCOCK
K896562 · GCX
Westmark, Sterile Packing Systems,...
General Hospital · 81d
Cleared Feb 06, 1990
TUBING CONNECTORS
K896563 · GCX
Westmark, Sterile Packing Systems,...
General Hospital · 81d
Cleared Feb 06, 1990
OLYMPIC LIGHT-WARM
K896611 · KZF
Olympic Medical Corp.
General Hospital · 77d
Cleared Feb 06, 1990
WEBER PERMALOCK
K896669 · LZO
Allo Pro Corp.
Orthopedic · 71d
Cleared Feb 06, 1990
MOD-ML UNICOMPARTMENTAL KNEE PROSTHESIS
K896856 · HSX
Osteonics Corp.
Orthopedic · 63d
Cleared Feb 06, 1990
ARTEC RESPOND PULMONARY RESUSCITATOR
K896886 · BTM
Artec Environmental Monitoring Division
Anesthesiology · 60d
Cleared Feb 06, 1990
LAPAROSCOPIC ACCESS SHEATH SET
K897064 · HET
Cook Ob/Gyn
Obstetrics & Gynecology · 48d
Cleared Feb 06, 1990
R-100-ET MANUAL COLLIMATOR
K900007 · IZX
Advantech
Radiology · 35d
Cleared Feb 05, 1990
TMI LW-100 PULSED DOPPLER SYSTEM
K893861 · IYN
Titronics Medical Instruments, Inc.
Radiology · 256d
Cleared Feb 05, 1990
CIRCAMED HOLTER VERSION 4
K894956 · DPS
Circadian, Inc.
Cardiovascular · 185d
Cleared Feb 05, 1990
SUPPLEMENT TO ANAEROBIC MIC PANEL
K896332 · JWY
Microtech Medical Systems, Inc.
Microbiology · 95d
Cleared Feb 05, 1990
PERCOR STAT-DL 9.5 FR & STAT-SL 8.5 FR INTRA-AORTI
K896430 · DSP
Datascope Corp.
Cardiovascular · 89d
Cleared Feb 05, 1990
CARDIAC COOLING JACKET, 8 CM, MODEL CJ-420
K896971 · DWC
Daily Medical Products, Inc.
Cardiovascular · 54d
Cleared Feb 05, 1990
CARDIAC COOLING JACKET, 12 CM, MODEL CJ-520
K896972 · DWC
Daily Medical Products, Inc.
Cardiovascular · 54d