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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
113113–113136 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 18, 1993
11274 AC FLEXINBLE CHOLEDOCHOSCOPE
K931382 · FBN
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 92d
Cleared Jun 18, 1993
COM-TENS (SINGLE MODE)
K931570 · GZJ
Ems Dist.
Neurology · 80d
Cleared Jun 18, 1993
CHECKPOINT
K931947 · JPK
Medical Specialties, Inc.
Hematology · 60d
Cleared Jun 17, 1993
VARIOUS STERILE CUSTOM DRESSING TRAYS & KITS
K912351 · LYY
Surgipro, Inc.
General Hospital · 751d
Cleared Jun 17, 1993
KIT PAK'S FLUSHING KIT
K922051 · KOD
Kit Pak, Inc.
Gastroenterology & Urology · 412d
Cleared Jun 17, 1993
DISPOSABLE MULTI-PUNCTURE APPLICATOR
K922177 · SCL
Allergy Extract Co.
General Hospital · 405d
Cleared Jun 17, 1993
4 SURE TM ENEMA BAG SET
K922398 · FCE
Boston Pacific Medical, Inc.
Gastroenterology & Urology · 392d
Cleared Jun 17, 1993
SURGICAL INSTRUMENT KIT, DISPOSABLE
K923175 · FMC
Ulti-Med Intl., Inc.
General Hospital · 370d
Cleared Jun 17, 1993
SURGICAL INSTRUMENT KIT, DISPOSABLE
K923176 · KDD
Ulti-Med Intl., Inc.
General & Plastic Surgery · 370d
Cleared Jun 17, 1993
SHAWNEE PRODUCT KIT IV
K923319 · KGX
Absentee Shawnee Bandage Group
General & Plastic Surgery · 345d
Cleared Jun 17, 1993
ACCU-DROP I.V. EXTENSION SET
K923560 · FPA
Lamtic, Inc.
General Hospital · 335d
Cleared Jun 17, 1993
IRRIGATION TRAY W/ PISTON SYRINGE & STERILE WATER
K923938 · EYN
American Healthcare Corp.
General & Plastic Surgery · 316d
Cleared Jun 17, 1993
IRRIGATION TRAY W/ BULB SYRINGE & STERILE WATER
K923939 · EYN
American Healthcare Corp.
General & Plastic Surgery · 316d
Cleared Jun 17, 1993
IRRIGATION TRAY W/ PISTON SYRINGE & STERILE SALINE
K923940 · EYN
American Healthcare Corp.
General & Plastic Surgery · 316d
Cleared Jun 17, 1993
IRRIGATION TRAY W/ BULB SYRINGE & STERILE SALINE
K923941 · EYN
American Healthcare Corp.
General & Plastic Surgery · 316d
Cleared Jun 17, 1993
SANKEN MAT
K924005 · FNM
Shima American Corp.
General Hospital · 311d
Cleared Jun 17, 1993
SNAP-LOCK MICROPORT - REVISED
K924505 · LJT
Strato Medical Corp.
General Hospital · 286d
Cleared Jun 17, 1993
VARIOUS ANESTHETIC KITS OR TRAYS
K924707 · CAZ
Specialty Medical Products Co.
Anesthesiology · 272d
Cleared Jun 17, 1993
100 LIGHT CURE UNIT
K924727 · EBF
Rolence Enterprise Co. , Ltd.
Dental · 269d
Cleared Jun 17, 1993
I.V. START KIT
K924811 · LRS
Transidyne General Corp.
General & Plastic Surgery · 265d
Cleared Jun 17, 1993
MODEL 285 INFUSION PUMP, MODIFICATION
K924865 · FRN
3M Health Care, Ltd.
General Hospital · 267d
Cleared Jun 17, 1993
MODEL 285CM INFUSION PUMP, MODIFICATION
K924866 · FRN
3M Health Care, Ltd.
General Hospital · 267d
Cleared Jun 17, 1993
285CI INFUSION PUMP, MODIFICATION
K924867 · FRN
3M Health Care, Ltd.
General Hospital · 267d
Cleared Jun 17, 1993
MODEL 480 INFUSION PUMP, MODIFICATION
K924868 · FRN
3M Health Care, Ltd.
General Hospital · 267d