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
168817–168840 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 03, 1979
HLA CONTROL SERA
K791118 · LGO
Calbiochem-Behring Corp.
Hematology · 49d
Cleared Aug 03, 1979
BUFFERIZER
K791144 · JJN
Helena Laboratories
Chemistry · 46d
Cleared Aug 03, 1979
ARCO PROGAMMABLE PACEMAKER SYSTEM
K791147 · DXY
Arco Medical Products Co.
Cardiovascular · 46d
Cleared Aug 03, 1979
TCO2M MODEL 818
K791152 · KLK
Novametrix Medical Systems, Inc.
Anesthesiology · 45d
Cleared Aug 03, 1979
ACTA-SCANNER 0220FS
K791153 · JAK
Pfizer, Inc.
Radiology · 45d
Cleared Aug 03, 1979
PFIZER 0200FS LOCALLZER
K791163 · JAK
Pfizer, Inc.
Radiology · 39d
Cleared Aug 03, 1979
DEXIDE DISPOSABLE PREP PAD
K791167 · FRL
Dexide, Inc.
General Hospital · 39d
Cleared Aug 03, 1979
ANESTHESIA OXYGEN ANALYZER MODEL 101
K791199 · CCL
Rule Medical Instruments, Inc.
Anesthesiology · 36d
Cleared Aug 03, 1979
IVAC 833 ELECTRONIC THERMOMETER
K791208 · FLL
Y
General Hospital · 32d
Cleared Aug 03, 1979
IVAC 819 ELECTRONIC THERMOMETER
K791209 · FLL
Y
General Hospital · 32d
Cleared Aug 03, 1979
BINDAFIX
K791211 · FQM
Conphar, Inc.
General Hospital · 32d
Cleared Aug 03, 1979
FLOWMETER, BACK PRESSURE COMPENSATED,
K791220 · CAX
Timeter Instrument Corp.
Anesthesiology · 31d
Cleared Aug 03, 1979
PLATELET-CHEX PLUS
K791226 · JPK
Streck Laboratories, Inc.
Hematology · 32d
Cleared Aug 03, 1979
PARA-7
K791227 · JPK
Streck Laboratories, Inc.
Hematology · 32d
Cleared Aug 03, 1979
PARA-8
K791228 · JPK
Streck Laboratories, Inc.
Hematology · 32d
Cleared Aug 03, 1979
LUBRICATING JELLY
K791243 · KMJ
Abco Dealers, Inc.
General Hospital · 25d
Cleared Aug 03, 1979
CONPHAR EXTERNAL CATHETER
K791245 · KNX
Conphar, Inc.
Gastroenterology & Urology · 28d
Cleared Aug 03, 1979
CONPHAR STOMACH TUBE-STERILE-X-RAY
K791250 · KNT
Conphar, Inc.
Gastroenterology & Urology · 28d
Cleared Aug 03, 1979
CONPHAR LEG BAG-STERILE
K791251 · KNX
Conphar, Inc.
Gastroenterology & Urology · 28d
Cleared Aug 03, 1979
CONPHAR SILICONE DRAINS-STERILE
K791254 · KDQ
Conphar, Inc.
General Hospital · 28d
Cleared Aug 03, 1979
SECUTEX SURGICAL BINDER
K791256 · FQM
Conphar, Inc.
General Hospital · 28d
Cleared Aug 03, 1979
CONPHAR FEEDING TUBE-STERILE
K791257 · KNT
Conphar, Inc.
Gastroenterology & Urology · 28d
Cleared Aug 03, 1979
CONPHAR URINARY DRAINAGE BAG 2000ML
K791262 · KNX
Conphar, Inc.
Gastroenterology & Urology · 28d
Cleared Aug 03, 1979
CONPHAR NELATON CATHETER-STERILE
K791264 · KOD
Conphar, Inc.
Gastroenterology & Urology · 28d