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
171913–171936 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 20, 1978
ANTITHROMBIN III RIA
K780012 · DDQ
Ria Diagnostics
Hematology · 17d
Cleared Jan 20, 1978
CULTURE MEDIA/ISOLA. PATHO. NEISSERIA
K780022 · JTY
Diagnostic Culture System
Microbiology · 16d
Cleared Jan 20, 1978
FLUORESCENCE DETECTOR MODEL 420
K780031 · KHO
Waters Assoc., Inc.
Toxicology · 11d
Cleared Jan 20, 1978
DENTAL HANDPIECE
K780038 · EFB
Lares Manufacturing Co., Inc.
Dental · 11d
Cleared Jan 20, 1978
AMINOGLYCOSIDE TEST SYSTEM
K780048 · DID
Nichols Institute Diagnostics
Immunology · 11d
Cleared Jan 20, 1978
PROSTHESIS, DOUBLE CUP
K780052 · JDI
Depuy, Inc.
Orthopedic · 11d
Cleared Jan 20, 1978
RUBENOSTICON
K780063 · GOK
Organon, Inc.
Microbiology · 8d
Cleared Jan 20, 1978
HEARING AID, BEHIND-THE-EAR
K780067 · ESD
Maico Hearing Instruments, Inc.
Ear, Nose, Throat · 8d
Cleared Jan 17, 1978
INSPIRON MANIFOLD (DOUBLE)
K772294 · CAF
C.R. Bard, Inc.
Anesthesiology · 35d
Cleared Jan 17, 1978
INSPIRON MANIFOLD (SINGLE)
K772295 · CAF
C.R. Bard, Inc.
Anesthesiology · 35d
Cleared Jan 17, 1978
INSPIRON MANIFOLD
K772296 · CAF
C.R. Bard, Inc.
Anesthesiology · 35d
Cleared Jan 17, 1978
DENTAL LIGHT
K772351 · EAZ
Chemetron Dental Products
Dental · 26d
Cleared Jan 17, 1978
PULSE GENERATORS
K772357 · DXY
Medtronic Vascular
Cardiovascular · 21d
Cleared Jan 17, 1978
BARRAQUER OVAL SPECULUM-VARIOUS SIZES
K772370 · EPY
Edward Weck, Inc.
General & Plastic Surgery · 21d
Cleared Jan 17, 1978
ROLLER KNIFE
K772372 · JYO
Edward Weck, Inc.
Ear, Nose, Throat · 21d
Cleared Jan 17, 1978
HILDYARD POST NASAL FORCEP
K772377 · KAE
Edward Weck, Inc.
Ear, Nose, Throat · 21d
Cleared Jan 17, 1978
FARRIOR OVAL SPECULUM
K772380 · EPY
Edward Weck, Inc.
General & Plastic Surgery · 21d
Cleared Jan 17, 1978
RING HANDLE & RETRACTORS
K772381 · KAL
Edward Weck, Inc.
Ear, Nose, Throat · 21d
Cleared Jan 17, 1978
MYRINGOTOMY KNIFE
K772384 · JYO
Edward Weck, Inc.
Ear, Nose, Throat · 21d
Cleared Jan 17, 1978
THIN-BLADED NASAL SPECULUM
K772385 · EPY
Edward Weck, Inc.
General & Plastic Surgery · 21d
Cleared Jan 17, 1978
DAY EAR HOOK
K772390 · JYL
Edward Weck, Inc.
Ear, Nose, Throat · 21d
Cleared Jan 17, 1978
BOIES NASAL FRACTURE ELEVATOR
K772391 · KAD
Edward Weck, Inc.
Ear, Nose, Throat · 21d
Cleared Jan 17, 1978
ALLPORT MASTOID RETRACTORS
K772392 · KAL
Edward Weck, Inc.
Ear, Nose, Throat · 21d
Cleared Jan 17, 1978
ALLIGATOR CUP FORCEPS
K772396 · KAE
Edward Weck, Inc.
Ear, Nose, Throat · 21d