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
160081–160104 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 01, 1982
ULTRAZYME PLUS CK-I, #64978,65027&65028
K821460 · CGS
Emd Chemicals, Inc.
Chemistry · 14d
Cleared Jun 01, 1982
ULTRACHEM T-BILI, #64971
K821462 · CIG
Emd Chemicals, Inc.
Chemistry · 14d
Cleared Jun 01, 1982
ULTRAZYME PLUS LDH, #64950,65038&65039
K821466 · CFJ
Emd Chemicals, Inc.
Chemistry · 14d
Cleared Jun 01, 1982
ULTRAZYME PLUS GOT, #64953,65033&65034
K821467 · CIT
Emd Chemicals, Inc.
Chemistry · 14d
Cleared Jun 01, 1982
LITTMAN OXGAL AGAR
K821493 · JSJ
Granite Diagnostics, Inc.
Microbiology · 14d
Cleared Jun 01, 1982
VERSACHEM ANALYZER
K821561 · JJQ
Emd Chemicals, Inc.
Chemistry · 7d
Cleared May 28, 1982
WORLD'S BEST (CONTRACEPTIVE)
K820564 · HIS
Rosen Kilde Stenhoj
Obstetrics & Gynecology · 87d
Cleared May 28, 1982
DISPOSABLE MULTIPLE LIGATING CLIP
K820837 · GDO
Ethicon, Inc.
General & Plastic Surgery · 63d
Cleared May 28, 1982
H-H ALIMENTATION CATHETERS
K821012 · LFJ
Holter-Hausner Intl.
Gastroenterology & Urology · 46d
Cleared May 28, 1982
CORATOMIC MODEL OVALITH 920BP
K821014 · DXY
Coratomic, Inc.
Cardiovascular · 46d
Cleared May 28, 1982
CORATOMIC MODEL OVALITH-920
K821033 · DXY
Coratomic, Inc.
Cardiovascular · 45d
Cleared May 28, 1982
OHIO ABSORBER
K821144 · BSF
Ohio Medical Products
Anesthesiology · 37d
Cleared May 28, 1982
SERIES 4 LIQUID CHROMATOGRAPH
K821219 · LDM
The Perkin-Elmer Corp.
Toxicology · 31d
Cleared May 28, 1982
SOFTIC 49
K821230 · EBI
The Healthcare Group Laboratories, Inc.
Dental · 31d
Cleared May 28, 1982
CC-700 SEVEN PARAMETER, AUTOMATED HEMAA
K821238 · GKL
Dysmex
Hematology · 30d
Cleared May 28, 1982
ROCHESTER PEAN FORCEPS
K821248 · GEN
Conphar, Inc.
General & Plastic Surgery · 25d
Cleared May 28, 1982
MAYO SCISSOR STRAIGHT 6 3/4
K821273 · EGM
Conphar, Inc.
Dental · 25d
Cleared May 28, 1982
MAYO SCISSOR STRAIGHT 5 1/2
K821275 · EGN
Conphar, Inc.
Dental · 25d
Cleared May 28, 1982
MAYO SCISSOR CURYED 5 1/2
K821276 · EGN
Conphar, Inc.
Dental · 25d
Cleared May 28, 1982
THUMB DRESSING FORCEPS 5
K821282 · EFL
Conphar, Inc.
Dental · 25d
Cleared May 28, 1982
ADSON FORCEPS 4 3/4
K821284 · EFL
Conphar, Inc.
Dental · 24d
Cleared May 28, 1982
SPLINTER FORCEPS 4 1/2
K821285 · EFL
Conphar, Inc.
Dental · 24d
Cleared May 28, 1982
IRIS SCISSORS STRAIGHT 4 1/2
K821286 · HNF
Conphar, Inc.
Ophthalmic · 24d
Cleared May 28, 1982
LITTAUER SCISSORS 5 1/2
K821290 · HNF
Conphar, Inc.
Ophthalmic · 24d